BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE— 510(k) K921388

Name: FDA 510(k) clearance K921388
Creator: U.S. Food and Drug Administration
Published: 1993-05-26

Substantially Equivalent

Biochem International, Inc.

FDA 510(k) clearance K921388 for BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE, Substantially Equivalent on 1993-05-26. Applicant: Biochem International, Inc.. Device class: 2.

Clearance details

Applicant: Biochem International, Inc.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 1992-03-23
Decision date: 1993-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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