SMARTHEART

Transmitters And Receivers, Electrocardiograph, Telephone

SHL TELEMEDICINE INTERNATIONAL LTD.

The following data is part of a premarket notification filed by Shl Telemedicine International Ltd. with the FDA for Smartheart.

Pre-market Notification Details

• Device ID: K113514
• 510k Number: K113514
• Device Name: SMARTHEART
• Classification: Transmitters And Receivers, Electrocardiograph, Telephone
• Applicant: SHL TELEMEDICINE INTERNATIONAL LTD. 31 HAAVODA ST. Binyamina, IL 30500
• Contact: Yoram Levy
• Correspondent: Yoram Levy; SHL TELEMEDICINE INTERNATIONAL LTD. 31 HAAVODA ST. Binyamina, IL 30500
• Product Code: DXH
• CFR Regulation Number: 870.2920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-28
• Decision Date: 2012-02-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290008960359	K113514	000