VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8— 510(k) K092653

Name: FDA 510(k) clearance K092653
Creator: U.S. Food and Drug Administration
Published: 2009-09-18

Substantially Equivalent

Medcom GmbH

FDA 510(k) clearance K092653 for VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8, Substantially Equivalent on 2009-09-18. 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: 2009-08-28
Decision date: 2009-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Darmstadt, Hessen, 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.