Lifewatch

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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

Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (8) Detector And Alarm, Arrhythmia (DSI) (6) Recorder, Magnetic Tape, Medical (DSH) (2)

Premarket Exempt

Clear

LifeWatch Mobile Cardiac Telemetry 3-Lead - 00850725007002 Catalog Number :

Device Description : 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Ozone/Windows/Verizon)

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DXH, DSI

Prescription Use : Yes

Device Count : 1

LifeWatch Mobile Cardiac Telemetry 3-Lead - 00850725007019 Catalog Number :

Device Description : 3 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/Verizon)

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DXH, DSI

Prescription Use : Yes

Device Count : 1

LifeWatch Mobile Cardiac Telemetry 3-Lead - 00850725007026 Catalog Number :

Device Description : 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Brigadier/Android/Verizon)

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DXH, DSI

Prescription Use : Yes

Device Count : 1

LifeWatch Mobile Cardiac Telemetry 3-Lead - 00850725007033 Catalog Number :

Device Description : 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DXH, DSI

Prescription Use : Yes

Device Count : 1

LifeWatch Mobile Cardiac Telemetry 1 Lead Patch - 00850725007040 Catalog Number :

Device Description : ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/ ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DXH, DSI

Prescription Use : Yes

Device Count : 1

MicroER - 00850725007057 Catalog Number :

Device Description : Personal Electrocardiogram (ECG) Transmitter

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Explorer - 00850725007064 Catalog Number :

Device Description : Card Guard Personal Electrocardiogram Transmitter

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

King of Hearts AF - 00850725007071 Catalog Number :

Device Description : King of Hearts Express AF Cardiac Event Recorder

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Lifestar AF Express - 00850725007088 Catalog Number :

Device Description : King of Hearts Express + AF Monitor

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

LifeWatch Mobile Cardiac Telemetry 3-Lead - 00850725007095 Catalog Number :

Device Description : 3 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/ATT)

Device Class : 2

Duns Number: 797936734

Premarket Exempt : No

Product Code : DXH, DSI

Prescription Use : Yes

Device Count : 1

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