COMMWELL RESEARCH & DEVELOPMENT LTD.

Address:yad haruzim 4,kfar saba Central,IL

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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

Electrocardiograph (DPS) (2) Electrode, Electrocardiograph (DRX) (1) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (1)

Premarket Exempt

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Commwell - 07290012672019 Catalog Number : 5-045-00

Device Description : An instrument designed to measure electrical potentials on the body surface to g An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity. [i.e., an electrocardiogram (ECG) for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of the 12-lead recording of the same heartbeat. It records data in electronic form for later analysis by software or a healthcare professional.

Device Class : 2

Duns Number: 532013976

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Commwell - 07290012672026 Catalog Number : 5-056-00

Device Description : An instrument designed to measure electrical potentials on the body surface to g An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of 12-lead recording of the same heartbeat. It records data in electronic or printed form for Bluetooth transmission to a mobile device for later Wi-Fi or GSM transmission to a predefined web server for analysis by software or by a healthcare professional.

Device Class : 2

Duns Number: 532013976

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Commwell - 07290012672057 Catalog Number : 5-001-00

Device Description : An instrument designed to measure electrical potentials on the body surface to g An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of 12-lead recording of the same heartbeat. It records data in electronic or printed form for Bluetooth transmission to a mobile device for later Wi-Fi or GSM transmission to a predefined web server for analysis by software or by a healthcare professional.

Device Class : 2

Duns Number: 532013976

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Commwell - 07290012672064 Catalog Number : 5-058-00

Device Class : 2

Duns Number: 532013976

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

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