Product Code: DPS


Products Classified as DPS

726ElectrocardiographElectrocardiograph.

Total Product Life Cycle (TPLC) Devices

726ElectrocardiographElectrocardiograph.

FDA Consensus Standards

Electrocardiograph [33227]21 CFR §870.2340 🔎
Electrocardiograph [31353]21 CFR §870.2340 🔎
Electrocardiograph [36790]21 CFR §870.2340 🔎
Electrocardiograph [38691]21 CFR §870.2340 🔎

Pre-market Notifications for DPS

K220362LE-12CHCAF Medical Solutions Inc.
K212278ElectrocardiographEdan Instruments, Inc.
K212163Coala Heart MonitorCoala Life AB
K212112Cardiologs Holter PlatformCardiologs Technologies
K210753KardiaMobile 6LAliveCor, Inc.
K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 CardiographPhilips Medical Systems
K210140Electrocardiograph: SE-1202Edan Instruments, Inc
K203786MAC 7 - Resting ECG Analysis SystemGE Medical Systems Information Technologies, Inc.
K201456Scan MonitorWithings SA
K200036AI-ECG TrackerShenzhen Carewell Electronics Co., Ltd.
K193415PhysIQ Heart Rhythm And Respiration ModulePhysIQ, Inc
K191692KardioScreenIMedrix Inc. (formerly Piitech Inc.)
K183425CARDIOVIT AT-102 G2Schiller AG
K183369COR12 ECGCorscience GmbH & Co.
K183322PhysIQ Heart Rhythm And Respiratory ModulePhysIQ, Inc

Global Unique Device Identification Database

00613994533340ELECTROCARDIOGRAPH
00613994533265ELECTROCARDIOGRAPH
00613994533241ELECTROCARDIOGRAPH
00643169876927ELECTROCARDIOGRAPH
00643169552296ELECTROCARDIOGRAPH
00643169345058ELECTROCARDIOGRAPH
00732094222302ELECTROCARDIOGRAPH
00732094199321ELECTROCARDIOGRAPH
00732094192254ELECTROCARDIOGRAPH
00732094185133ELECTROCARDIOGRAPH
00732094181692ELECTROCARDIOGRAPH
00732094181562ELECTROCARDIOGRAPH
00732094179637ELECTROCARDIOGRAPH
00732094177640ELECTROCARDIOGRAPH
00732094177633ELECTROCARDIOGRAPH

Maude Adverse Events

KARDIAMOBILEALIVECOR, INC.2020-03-03
PAGEWRITERPHILIPS MEDICAL SYSTEMS2020-02-25
STRESSVUEPHILIPS MEDICAL SYSTEMS2020-01-06
STRESSVUEPHILIPS MEDICAL SYSTEMS2020-01-06
M SERIESZOLL MEDICAL CORPORATION2019-10-10
ELECTROCARDIOGRAPHGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.2019-09-26
KARDIAMOBILEALIVECOR2019-09-06
ECG-1350ANIHON KOHDEN CORPORATION2019-09-05
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-08-07
M SERIESZOLL MEDICAL CORPORATION2019-08-07
PAGEWRITER TC30 CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-08-05
IQECGMIDMARK CORPORATION2019-07-17
CARDIOFAX MNIHON KOHDEN CORPORATION2019-07-03
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-06-22
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-06-22
M SERIESZOLL MEDICAL CORPORATION2019-05-21
M SERIESZOLL MEDICAL CORPORATION2019-04-10
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-04-01
M SERIESZOLL MEDICAL CORPORATION2019-03-29
M SERIESZOLL MEDICAL CORPORATION2019-03-15
M SERIESZOLL MEDICAL CORPORATION2019-03-14
M SERIESZOLL MEDICAL CORPORATION2019-03-14
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-03-12
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-03-08
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-03-08
M SERIESZOLL MEDICAL CORPORATION2019-03-08
PAGEWRITER TC20 CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2019-03-05
NASIFF ASSOCIATES EKG SOFTWARENASIFF ASSOCIATES, INC.2019-01-28
M SERIESZOLL MEDICAL CORPORATION2019-01-08
M SERIESZOLL MEDICAL CORPORATION2018-12-26
M SERIESZOLL MEDICAL CORPORATION2018-12-20
M SERIESZOLL MEDICAL CORPORATION2018-11-19
PAGEWRITER TC20 CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2018-11-06
PACEART SYSTEMMEDTRONIC, INC.2018-10-31
MAC 5500 HDGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES2018-10-26
STRESS TESTMORTARA INSTRUMENT, INC.2018-09-25
MORTARAMORTARA INSTRUMENT, INC2018-09-20
STRESSVUEPHILIPS MEDICAL SYSTEMS2018-09-11
MAC 5500 HDGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC2018-08-20
VERMED ECG MONITORING ELECTRODESNISSHA FIS, INC2018-08-13
M SERIESZOLL MEDICAL CORPORATION2018-07-17
GE 5500 EKG MACHINEGE HEALTHCARE2018-05-21
ALIVECOR KARDIABANDALIVECOR, INC.2018-05-21
PAGEWRITER TC20 CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2018-05-16
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2018-05-15
M SERIESZOLL MEDICAL CORPORATION2018-03-02
ELI 380MORTARA INSTRUMENT, INC.2018-02-28
PAGEWRITER TOUCH CARDIOGRAPHPHILIPS MEDICAL SYSTEMS2018-02-20
PHILIPS PAGEWRITER TC-70 CARDIOGRAPH MACHINESPHILIPS2017-12-12
M SERIESZOLL MEDICAL CORPORATION2017-12-08

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