OMEGA ANGIOSCOPES (OMEGASCOPES)— 510(k) K911090

Name: FDA 510(k) clearance K911090
Creator: U.S. Food and Drug Administration
Published: 1991-07-31

Substantially Equivalent

Omega Universal Technologies, Ltd.

FDA 510(k) clearance K911090 for OMEGA ANGIOSCOPES (OMEGASCOPES), Substantially Equivalent on 1991-07-31. Applicant: Omega Universal Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Omega Universal Technologies, Ltd.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-03-11
Decision date: 1991-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, NJ, US

Download summary PDF View on FDA.gov ↗

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