510(k) Report

Devices descending from K973985

400 later devices reach AS/3 Anaesthesia Delivery Unit (as/3 Adu) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+6K123211A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division201381
+6K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+6K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+6K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+6K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB20123Class I
+6K103803Hamilton-G5Hamilton Medical AG201114Class I
+6K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+6K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+6K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+6K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB20114—
+6K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+6K102775Hamilton-C2Hamilton Medical AG201114—
+6K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+6K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+6K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc.20104—
+6K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+6K090468Hamilton-C2Hamilton Medical AG20090—
+6K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+6K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+6K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+6K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+6K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+7K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+7K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K233486731 Series VentilatorZOLL Medical Corporation20240—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+7K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+7K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+7K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+7K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+7K211046eCareManager 4.5Visicu, Inc.20220—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+7K210160AlertWatch:ACAlertwatch, Inc.20210—
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+7K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+7K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+7K192514Patient MonitorEdan Instruments, Inc.202061
+7K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K180017MX40 Release C.01Philips Medical Systems20181—
+7K172875Astral 100/150Resmed, Ltd.20180Class I
+7K173715AlertWatch:OBAlertwatch, Inc.20180—
+7K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+7K171311A5 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K161056Telemetry TransmitterEdan Instruments, Inc.201702
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+7K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+7K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+7K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB20142Class I
+7K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+7K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+7K131774Hamilton-G5Hamilton Medical AG201310Class I
+7K131032Philips Suresigns CentralPhilips Medical Systems20131—
+7K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+7K121225Hamilton-C2Hamilton Medical AG20128Class I
+7K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+7K112006Hamilton-TC1Hamilton Medical AG201213—
+7K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+7K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+7K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+7K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+7K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+7K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+8K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+8K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+8K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+8K233452Vivo 45 LSBreas Medical AB202501
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K241397HinscopeHinlab Sas20240—
+8K240756Aitrics-VCAitrics Co., Ltd.20240—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—