510(k) Report

Devices descending from K955642

817 later devices reach Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+7K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+7K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+7K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+7K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+7K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+7K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+7K141774Zoll X SeriesZOLL Medical Corporation20142—
+7K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+7K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+7K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+7K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+7K131032Philips Suresigns CentralPhilips Medical Systems20131—
+7K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+7K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+7K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+7K130056Patient MonitorLd Technology, LLC20130—
+7K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+7K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+7K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+7K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+7K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+7K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+7K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+7K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+7K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+7K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+7K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+8K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K260880SedLine Sedation MonitorMasimo Corporation20260—
+8K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+8K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+8K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+8K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+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—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+8K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+8K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K233216CLEWICU SystemClew Medical, Ltd.20240—
+8K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+8K223711ANNE OneSibel Health, Inc.20234—
+8K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+8K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+8K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+8K221530ANNE PediatricSibel, Inc.20220—
+8K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K213230T3 Platform SoftwareEtiometry, Inc.202212—
+8K211046eCareManager 4.5Visicu, Inc.20220—
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+8K212219AHI SystemFifth Eye, Inc.20211—
+8K210160AlertWatch:ACAlertwatch, Inc.20210—
+8K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+8K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+8K202375ZOLL Propaq MZOLL Medical Corporation20211—
+8K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+8K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+8K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+8K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+8K191882Masimo Centroid SystemMasimo Corporation20203—
+8K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+8K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+8K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.201915—
+8K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+8K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+8K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+8K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+8K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+8K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+8K180017MX40 Release C.01Philips Medical Systems20181—
+8K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+8K173715AlertWatch:OBAlertwatch, Inc.20180—