VYNTUS/ SENTRYSUITE PRODUCT LINE— 510(k) K133925

Name: FDA 510(k) clearance K133925
Creator: U.S. Food and Drug Administration
Published: 2014-08-22

Substantially Equivalent

Carefusion Germany 234 GmbH

FDA 510(k) clearance K133925 for VYNTUS/ SENTRYSUITE PRODUCT LINE, Substantially Equivalent on 2014-08-22. Applicant: Carefusion Germany 234 GmbH. Device class: 2.

Clearance details

Applicant: Carefusion Germany 234 GmbH
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 2013-12-23
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechberg, DE

Download summary PDF View on FDA.gov ↗

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