VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE— 510(k) K133914

Name: FDA 510(k) clearance K133914
Creator: U.S. Food and Drug Administration
Published: 2014-04-03

Substantially Equivalent

Medcom GmbH

FDA 510(k) clearance K133914 for VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE, Substantially Equivalent on 2014-04-03. Applicant: Medcom GmbH. Device class: 2.

Clearance details

Applicant: Medcom GmbH
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2013-12-23
Decision date: 2014-04-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Darmstadt, 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.