CARDIOSEN'C— 510(k) K080047

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..

Clearance details

Applicant: Shl Telemedicine International , Ltd.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2008-01-08
Decision date: 2008-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

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