CLUE MEDICAL AND CLUE MEDICAL BASIC— 510(k) K083630

Name: FDA 510(k) clearance K083630
Creator: U.S. Food and Drug Administration
Published: 2009-04-23

Substantially Equivalent

Telovital GmbH Telemedizin

FDA 510(k) clearance K083630 for CLUE MEDICAL AND CLUE MEDICAL BASIC, Substantially Equivalent on 2009-04-23. Applicant: Telovital GmbH Telemedizin. Device class: 2.

Clearance details

Applicant: Telovital GmbH Telemedizin
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2008-12-08
Decision date: 2009-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

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