BIOCHEM 515 RESPIRATION MONITOR— 510(k) K854333

Name: FDA 510(k) clearance K854333
Creator: U.S. Food and Drug Administration
Published: 1986-05-30

Substantially Equivalent

Biochem International, Inc.

FDA 510(k) clearance K854333 for BIOCHEM 515 RESPIRATION MONITOR, Substantially Equivalent on 1986-05-30. Applicant: Biochem International, Inc.. Device class: 2.

Clearance details

Applicant: Biochem International, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1985-10-28
Decision date: 1986-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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