VITAPHONE. MODEL 100 BT— 510(k) K100383

Substantially Equivalent

Vitasystems GmbH

FDA 510(k) clearance K100383 for VITAPHONE. MODEL 100 BT, Substantially Equivalent on 2010-04-20. Applicant: Vitasystems GmbH. Device class: 2.

Clearance details

Applicant: Vitasystems GmbH
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2010-02-16
Decision date: 2010-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chemnitz, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.