SMARTHEART— 510(k) K113514

Name: FDA 510(k) clearance K113514
Creator: U.S. Food and Drug Administration
Published: 2012-02-22

Substantially Equivalent

Shl Telemedicine International , Ltd.

FDA 510(k) clearance K113514 for SMARTHEART, Substantially Equivalent on 2012-02-22. Applicant: Shl Telemedicine International , Ltd.. Device class: 2.

Clearance details

Applicant: Shl Telemedicine International , Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2011-11-28
Decision date: 2012-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

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