PO-510 TCPO2 MONITOR— 510(k) K852959

Name: FDA 510(k) clearance K852959
Creator: U.S. Food and Drug Administration
Published: 1985-11-29

Substantially Equivalent

Sumitomo Electric Industries, Inc.

FDA 510(k) clearance K852959 for PO-510 TCPO2 MONITOR, Substantially Equivalent on 1985-11-29. 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: 1985-07-12
Decision date: 1985-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osaka, 554 Japan, JP

Download summary PDF View on FDA.gov ↗

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