SENTRYSUITE PRODUCT LINE— 510(k) K111053

Name: FDA 510(k) clearance K111053
Creator: U.S. Food and Drug Administration
Published: 2011-08-12

Substantially Equivalent

Carefusion Germany 234 GmbH

FDA 510(k) clearance K111053 for SENTRYSUITE PRODUCT LINE, Substantially Equivalent on 2011-08-12. Applicant: Carefusion Germany 234 GmbH. Device class: 2.

Clearance details

Applicant: Carefusion Germany 234 GmbH
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2011-04-15
Decision date: 2011-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechberg, 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.