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DPS

576 FDA 510(k) clearances · Product code

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RecordFirmDate
DIGITAL ELECTROCARDIOGRAPHS (K131262)Sonoscape Company Limited2013-11-14
PHILIPS DXL 12/16-LEAD ECG ALGORITHM (K132068)Philips Medical Systems2013-09-26
ALIVECOR HEART MONITOR (K130409)AliveCor, Inc.2013-09-06
SPACELABS HEALTHCARE CARDIOEXPRESS (K130207)Spacelabs Healthcare, Ltd.2013-07-23
MICRO AMBULATORY ECG RECORDER (K131572)Dimetek Digital Medical Technologies, Ltd.2013-07-22
CP150 ELECTROCARDIOGRAPH (K131573)Welch Allyn, Inc.2013-07-03
CS-MAG II (K121825)Biomagnetik-Park GmbH2013-03-11
DIGITAL ELECTROCARDIOGRAPHS (K123816)Shenzhen Biocare Electronics Co., Ltd.2013-02-27
CARDEASCREEN (K123217)Cardea Associates, Inc.2013-02-05
QT GUARD PLUS ANALYSIS SYSTEM (K120770)Ge Medical Systems Information Technologies2012-12-06
ALIVECOR HEART MONITOR FOR IPHONE (K122356)AliveCor, Inc.2012-11-19
DIGITAL ELECTROCARDIOGRAPH (K122712)Shenzhen Biocare Electronics Co., Ltd.2012-10-25
ELI 280 ELECTROCARDIOGRAPH (K122073)Mortara Instrument, Inc.2012-08-02
HANDHELD ECG MONITOR (K112622)Beijing Choice Electronic Technololgy Co., Ltd.2012-07-19
RSCRIBE ELECTROCARDIOGRAPH (K120865)Mortara Instrument, Inc.2012-07-19
CARDIO 7 (K113306)Bionet Co., Ltd.2012-07-16
HEARTCHECK ECG PEN WITH GEMS HOME (K121009)Cardiocomm Solutions, Inc.2012-05-17
ELECTROCARDIOGRAPH (K113485)Shenzhen Carewell Electronics Co., Ltd.2012-04-25
PAGEWRITER TC 20, 30, 50, 70 (K113144)Philips Medical Systems2012-04-03
ELECTROCARDIOGRAPH (K120188)Edan Instruments, Inc.2012-03-16
CALG-STR EXERCISE ECG ANALYSIS ALGORITHM (K112959)Philips Health Care2012-01-26
HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME (K111159)Cardiocomm Solutions, Inc.2011-12-22
MOBCARDIO SYSTEM (K113234)Mobhealth Incorporation2011-11-17
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI (K102378)Vectracor, Inc.2011-11-02
PHYSIOGLOVE ES WITH ECG ANALYSIS (K103791)Commwell , Ltd.2011-10-21
DIGITAL ELECTROCARDIOGRAPH (K112431)Shenzhen Biocare Electronics Co., Ltd.2011-09-22
REKA E100 (K111438)Reka Pte, Ltd.2011-09-12
ECG SERIES ELECTROCARDIOGRAPH (K111805)Advanced Instrumentations, Inc.2011-08-24
ECG-6 SERIES ELECTROCARDIOGRAPH (K112135)Advanced Instrumentations, Inc.2011-08-05
ACG-8511 PORTABLE ECG MONITOR (K110328)Andon Health Co, Ltd.2011-07-15
ECG PEN (K103077)Meridian Dynamics Biomedical, Inc.2011-07-13
HERO (K111601)Medical Predictive Science Corp.2011-07-08
CARDIO XP (K102767)Bionet Co., Ltd.2011-06-03
MAC 600 RESTING ECG ANALYSIS SYSTEM (K103765)Ge Medical Systems Information Technologies, Inc.2011-05-17
MAC 5500 HD, MAC 3500 (K110266)Ge Medical Systems Information Technologies, Inc.2011-04-29
VICOR PD2I ANALYZER (K101867)Vicor Technologies, Inc.2011-04-14
MOBILEECG SYSTEM (K103427)Memtec Corp.2011-03-24
MIDMARK IQECG (K103640)Brentwood Medical Technology Corp.2011-03-22
SPAULDING IQ ELECTROCARDIOGRAPH (K110065)Spaulding Clinical Research, LLC2011-03-02
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER (K101569)Taidoc Technology Corporation2011-03-01
DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 (K101876)Shenzhen Biocare Electronics Co., Ltd.2011-03-01
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 (K102206)Mortara Instrument, Inc.2011-02-18
ANS SYSTEM (K101016)Caird Technology2011-01-28
PC ECG (K102854)Edan Instruments, Inc.2010-12-03
ELECTROCARDIOGRAPH (K102830)Edan Instruments, Inc.2010-12-02
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB (K100813)Pulse Biomedical, Inc.2010-07-23
ELI 250 ELECTROCARDIOGRAPH (K101403)Mortara Instrument, Inc.2010-07-02
ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 (K101115)Mortara Instrument, Inc.2010-06-18
CARECENTER MD (K093211)Cardiac Science Corporation2010-06-03
ELI 230 ELECTROCARDIOGRAPH (K100127)Mortara Instrument, Inc.2010-04-16
SE-601 SERIES ELECTROCARDIOGRAPH (K093869)Edan Instruments, Inc.2010-04-01
HANDHELD ECG MONITOR, MODEL MD100 (K093872)Beijing Choice Electronic Technololgy Co., Ltd.2010-03-31
ELI PC ELECTROCARDIOGRAPH (K093339)Mortara Instrument, Inc.2010-02-19
QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) (K093172)Dynacardia, Inc.2010-01-20
ELI 350 ELECTROCARDIOGRAPH (K092663)Mortara Instrument, Inc.2009-12-14
PC ECG, MODEL SE-1010 (K092010)Edan Instruments, Inc.2009-10-22
BELTBEAT WF-400 (K083715)Bonus Communicaciones Srl2009-09-15
GEM HEART ONE/ONE+ (K092576)Gem-Med S.L.2009-09-04
SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A (K090936)Contec Medical System Co., Ltd.2009-08-25
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 (K091513)Edan Instruments, Inc.2009-07-24
ECSCOPE 200 (K091397)Dyansys, Inc.2009-07-08
SE-601 SERIES ELECTROCARDIOGRAPH (K090367)Edan Instruments, Inc.2009-06-03
ECSCOPE 100 (K091358)Dyansys, Inc.2009-05-28
MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM (K090249)Harbinger Medical, Inc.2009-04-03
MORTARA STRESS ECHO BED (K082967)Medical Positioning, Inc.2009-03-26
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS (K090483)Philips Medical Systems2009-03-20
MAC 800 RESTING ECG ANALYSIS SYSTEM (K090212)Ge Medical Syst. Information Technologies2009-02-19
CARDITTE MICROTEL (K082124)Et Medical Devices Spa2009-02-19
VICOR PD2I ANALYZER, VERSION 2.1 (K082709)Vicor Technologies, Inc.2008-12-29
MORTARA ELI 350 ELECTROCARDIOGRAPH (K082946)Mortara Instrument, Inc.2008-12-29
VICARDIO 12B (K082380)Energy-Lab Technologies GmbH2008-12-03
CLUE MEDICAL AND CLUE MEDICAL BASIC (K082013)Telovital GmbH Telemedizin2008-11-10
HANDHELD ECG MONITOR, MODEL MD100 (K080933)Beijing Choice Electronic Technololgy Co., Ltd.2008-09-26
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) (K082312)Heartscape Technologies, Ltd.2008-09-12
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S (K082173)Cardiac Science Corporation2008-08-26
MAC 1600 ECG ANALYSIS SYSTEM (K081437)Ge Medical Systems Information Technologies2008-07-15
HERO, VERSION 2.0 (K081473)Medical Predictive Science Corp.2008-06-27
PAGEWRITER CARDIOGRAPH (K080999)Philips Medical Systems2008-05-09
QHRV 1 - HEALTH ASSESSMENT SYSTEM (K080884)Medtechs, LLC2008-04-11
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM (K073625)Ge Healthcare Systems Information Technologies2008-01-25
PORTABLE ECSCOPE 12I (K080036)Dyansys, Inc.2008-01-16
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS (K072449)Welch Allyn, Inc.2007-11-29
THE PORTABLE ANSISCOPE (K071168)Dyansys, Inc.2007-08-31
PORTABLE ECSCOPE (K072353)Dyansys Corp2007-08-30
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M (K072217)Nihon Kohden America, Inc.2007-08-30
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V (K072060)Nihon Kohden America, Inc.2007-08-17
PALM ECG RECORDER, MODEL EP-201/202 (K061123)Parama-Tech Company., Ltd.2007-06-29
CORSCREEN (K070614)Viasys Healthcare GmbH2007-05-04
AUDICOR 200 SYSTEM, MODELS 200D AND 200S (K070136)Inovise Medical, Inc.2007-04-13
MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 (K062282)Monebo Technologies, Inc.2007-03-22
MORTARA ELI 10 ELECTROCARDIOGRAPH (K070539)Mortara Instrument, Inc.2007-03-15
INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 (K062894)Dailycare Biomedical, Inc.2007-02-08
ELI 350 ELECTROCARDIOGRAPH (K062677)Mortara Instrument, Inc.2006-11-15
VOYAGER 12 (K062469)Del Mar Reynolds Medical, Ltd.2006-11-03
INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 (K062068)Intelwave, LLC2006-10-27
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 (K060766)Omron Healthcare, Inc.2006-06-09
CARDIOFAX CE, MODEL ECG-1500 A (K052511)Nihon Kohden America, Inc.2006-05-24
PHYSIOGLOVE ES (K050674)Commwell , Ltd.2006-04-25
ATRIA 3100, ATRIA 6100 (K060167)Cardiac Science Corporation2006-04-19
IQMARK EZ STRESS (K052898)Brentwood Medical Technology Corp.2006-03-28
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