GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT— 510(k) K941660

Name: FDA 510(k) clearance K941660
Creator: U.S. Food and Drug Administration
Published: 1994-05-24

Substantially Equivalent

Gm Engineering, Inc.

FDA 510(k) clearance K941660 for GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT, Substantially Equivalent on 1994-05-24. Applicant: Gm Engineering, Inc.. Device class: 2.

Clearance details

Applicant: Gm Engineering, Inc.
Product code: Code KYH
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-05
Decision date: 1994-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Verne, CA, US

Download summary PDF View on FDA.gov ↗

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