510(k) Report

Devices descending from K921669

233 later devices reach Marquette SL Series Transport Remote Acquisition through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K072884Fabius MriDraeger Medical AG & Co. KG20080Class I
+5K062469Voyager 12Del Mar Reynolds Medical, Ltd.20060—
+5K052057Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc.200643
+5K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc.200512
+5K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies200430—
+6K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+6K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.20250—
+6K232816Electrocardiograph, model: ECG301Shenzhen LE Medical Technology Co., Ltd.20240—
+6K223498Radius VSM and AccessoriesMasimo Corporation202312
+6K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+6K191323Carescape B850GE Healthcare Finland Oy202071
+6K191249Carescape B450GE Healthcare Finland Oy20204—
+6K171942ElectrocardiographEdan Instruments, Inc.20183—
+6K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+6K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+6K170995ElectrocardiographEdan Instruments, Inc.20173—
+6K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+6K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+6K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+6K131858Digital ElectrocardiographGuangdong Biolight Meditech Co., Ltd.20140—
+6K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+6K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+6K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+6K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+6K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+6K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+6K130056Patient MonitorLd Technology, LLC20130—
+6K123217CardeascreenCardea Associates, Inc.20130—
+6K122712Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20128—
+6K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc.20120Class I
+6K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+6K113485ElectrocardiographShenzhen Carewell Electronics Co., Ltd.20123—
+6K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+6K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+6K112431Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20119—
+6K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+6K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+6K073625Modification to: Mac 5500 Resting Ecg Analysis SystemGe Healthcare Systems Information Technologies20087—
+6K072596Life+Cel or Lifecel Battery Pack, Model 5L500Amco International Manufacturing & Design, Inc.20080—
+6K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251…Heartsine Technologies, Inc.20062Class I
+6K06083312SL Ecg Analysis ProgramGe Medical Systems Information Technologies200621—
+7K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K250757Radius VSM and AccessoriesMasimo Corporation20250—
+7K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+7K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+7K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+7K213336Carescape B850, E-musbGE Healthcare Finland Oy202221
+7K212278ElectrocardiographEdan Instruments, Inc.20222—
+7K220362LE-12CHCaf Medical Solutions, Inc.20220—
+7K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+7K191149Carescape B650GE Healthcare Finland Oy202072
+7K180432AI-ECG PlatformShenzhen Carewell Electronics., Ltd.20180—
+7K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+7K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+7K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+7K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+7K131900Contec ElectrocardiographContec Medical System Co., Ltd.20141—
+7K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+7K132758Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20141—
+7K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare20141—
+7K131262Digital ElectrocardiographsSonoscape Company Limited20130—
+7K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc.201311
+7K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+7K123816Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd.20134—
+7K103765Mac 600 Resting Ecg Analysis SystemGe Medical Systems Information Technologies, Inc.20110—
+7K110266Mac 5500 HD, Mac 3500Ge Medical Systems Information Technologies, Inc.20111—
+7K09236912SL Ecg Analysis ProgramGe Medical Systems Information Technologies201019—
+7K093172Quantitative Electrocardiographic Detector (Qed 1000)Dynacardia, Inc.20100—
+7K092663Eli 350 ElectrocardiographMortara Instrument, Inc.200901
+8K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+8K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+8K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd.20230—
+8K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+8K230415Cadwell GuardianCadwell Industries, Inc.20230—
+8K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+8K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame…GE Healthcare Finland Oy202313
+8K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+8K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+8K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+8K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K171360CONTEC™ ElectrocardiographContec Medical Systems Co.,Ltd20180—
+8K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+8K162012CARESCAPE Central Station V2GE Healthcare201676