BIOCHEM 8100 ANESTHETIC AGENT MONITOR— 510(k) K892646

Name: FDA 510(k) clearance K892646
Creator: U.S. Food and Drug Administration
Published: 1989-08-31

Substantially Equivalent

Biochem International, Inc.

FDA 510(k) clearance K892646 for BIOCHEM 8100 ANESTHETIC AGENT MONITOR, Substantially Equivalent on 1989-08-31. Applicant: Biochem International, Inc.. Device class: 2.

Clearance details

Applicant: Biochem International, Inc.
Product code: Code CBQ
Device class: Class 2
Regulation: 21 CFR 868.1500
Advisory panel: Anesthesiology
Date received: 1989-04-12
Decision date: 1989-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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