PO-200 BLOOD OXYGEN MONITOR— 510(k) K811836

Name: FDA 510(k) clearance K811836
Creator: U.S. Food and Drug Administration
Published: 1981-07-27

Substantially Equivalent

Sumitomo Electric Industries, Inc.

FDA 510(k) clearance K811836 for PO-200 BLOOD OXYGEN MONITOR, Substantially Equivalent on 1981-07-27. Applicant: Sumitomo Electric Industries, Inc.. Device class: 2.

Clearance details

Applicant: Sumitomo Electric Industries, Inc.
Product code: Code KLK
Device class: Class 2
Regulation: 21 CFR 868.2500
Advisory panel: Anesthesiology
Date received: 1981-06-30
Decision date: 1981-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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