CARDIOSEN'C— 510(k) K080047

Name: FDA 510(k) clearance K080047
Creator: U.S. Food and Drug Administration
Published: 2008-07-11

Substantially Equivalent

Shl Telemedicine International , Ltd.

FDA 510(k) clearance K080047 for CARDIOSEN'C, Substantially Equivalent on 2008-07-11. 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: 2008-01-08
Decision date: 2008-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

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