510(k) Report

Devices descending from K903644

60 later devices reach Series 1500 12-Lead Analysis Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973403Cardiosmart STMarquette Medical Systems, Inc.199834—
+1K973486Life Pak 12Physio-Control Corp.1998243
+2K102972Lifepak 12Physio-Control, Inc.201001
+2K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.200953
+2K081437Mac 1600 Ecg Analysis SystemGe Medical Systems Information Technologies20085—
+2K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.200772
+2K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.20049—
+2K040775Lifepak 12Medtronic Physio-Control Corp.2004101
+2K030898Mobile Battery Service Station (MBSS)Ad Elektronik GmbH20030—
+2K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp.20022117
+2K991014Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn199933—
+2K991910Lifepak 12 BiphasicPhysio-Control Corp.1999223
+3K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.20142Class I
+3K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc.20130Class I
+3K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.20114—
+3K090212Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies200941
+3K073089Lifepak 20EPhysio-Control, Inc.200811
+3K062331Highpak-12Ad Elektronik GmbH20070—
+3K063119Lifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc.200625
+3K052898Iqmark EZ StressBrentwood Medical Technology Corp.20060—
+3K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp.2003201
+3K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies200330—
+3K023380T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn200231—
+4K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control20241—
+4K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+4K140020Hyperq Acs-100 SystemBsp-Biiological Signal Processing, Ltd.20140—
+4K133622Mac 2000 Ecg Analysis SystemWipro GE Healthcare20141—
+4K103678Case Cardiac Testing System, CS Cardiac Testing SystemGe Medical Systems Information Technologies GmbH20111—
+4K102854PC ECGEdan Instruments, Inc.201013—
+4K093211Carecenter MDCardiac Science Corporation20101—
+4K092010PC Ecg, Model SE-1010Edan Instruments, Inc.200918—
+4K091594Heart-ExerciseGe Medical Systems Information Technologies GmbH20090—
+4K052057Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc.200643
+4K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc.200512
+5K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.20250—
+5K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemGe Medical Systems Information Technologies, Inc.202301
+5K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HTrismed Co., Ltd.20230—
+5K152384Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20150—
+5K133985Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20151—
+5K131503SE-601 Series ElectrocardiographEdan Instruments, Inc.20149—
+5K131819PC ECGEdan Instruments, Inc.201312—
+5K123217CardeascreenCardea Associates, Inc.20130—
+5K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc.20120Class I
+5K093869SE-601 Series ElectrocardiographEdan Instruments, Inc.201010—
+5K072596Life+Cel or Lifecel Battery Pack, Model 5L500Amco International Manufacturing & Design, Inc.20080—
+5K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251…Heartsine Technologies, Inc.20062Class I
+6K160876PC ECGEdan Instruments, Inc.20178—
+6K152427PC ECGEdan Instruments, Inc.201611—
+6K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc.201311
+7K171942ElectrocardiographEdan Instruments, Inc.20183—
+7K170995ElectrocardiographEdan Instruments, Inc.20173—
+7K161302PC ECGEdan Instruments, Inc.20161—
+7K142709samaritan PAD 450PHeartsine Technologies, Inc.20150—
+8K212278ElectrocardiographEdan Instruments, Inc.20222—
+8K220362LE-12CHCaf Medical Solutions, Inc.20220—
+8K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+8K191692KardioScreenImedrix Inc. (Formerly Piitech Inc.)20200—
+9K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+9K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+10K232210X-trodes System MX-Trodes20240—