IRHYTHM TECHNOLOGIES, INC.

Address:699 8th Street,San Francisco,CA,94103,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Recorder, Magnetic Tape, Medical (DSH) (4) Computer, Diagnostic, Programmable (DQK) (2) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (2) Detector And Alarm, Arrhythmia (DSI) (1)

Premarket Exempt

Clear

ZIO XT Patch - 00869770000203 Catalog Number :

Device Description : ZIO XT ECG Monitoring Service

Device Class : 2

Duns Number: 861237670

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

ZIO AT Patch - 00869770000210 Catalog Number :

Device Description : ZIO AT ECG Monitoring Service

Device Class : 2

Duns Number: 861237670

Premarket Exempt : No

Product Code : DQK, DSI, DXH, DSH

Prescription Use : Yes

Device Count : 1

ZIO SR Patch - 00869770000234 Catalog Number :

Device Description : ZIO SR ECG Monitoring Service

Device Class : 2

Duns Number: 861237670

Premarket Exempt : No

Product Code : DXH, DQK, DSH

Prescription Use : Yes

Device Count : 1

Zio monitor - 00869770000241 Catalog Number :

Device Class : 2

Duns Number: 861237670

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

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