MASTERSCREEN PAED - BABY BODY— 510(k) K081823

Name: FDA 510(k) clearance K081823
Creator: U.S. Food and Drug Administration
Published: 2009-05-18

Substantially Equivalent

Viasys Healthcare GmbH

FDA 510(k) clearance K081823 for MASTERSCREEN PAED - BABY BODY, Substantially Equivalent on 2009-05-18. Applicant: Viasys Healthcare GmbH. Device class: 2.

Clearance details

Applicant: Viasys Healthcare GmbH
Product code: Code CCM
Device class: Class 2
Regulation: 21 CFR 868.1750
Advisory panel: Anesthesiology
Date received: 2008-06-27
Decision date: 2009-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechberg, DE

Download summary PDF View on FDA.gov ↗

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