SHL TELEMEDICINE INTERNATIONAL LTD.

Address:90 Igal Alon Street,Tel-Aviv Tel Aviv,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

Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (1)

Premarket Exempt

Clear

smartheart - 07290008960359 Catalog Number :

Device Description : The smartheart is a personal, hand-held battery powered, 12 lead EGand rhythm st The smartheart is a personal, hand-held battery powered, 12 lead EGand rhythm strip device with Bluetooth connection. The smartheartacquires EGG data via attached electrodes. The smartheart transmits thedata in real-time to a suitable Bluetooth communication device forforwarding it to a remote location and a certified medical professionalcapable of interpreting the results.

Device Class : 2

Duns Number: 531817906

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

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