ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY— 510(k) K895538

Name: FDA 510(k) clearance K895538
Creator: U.S. Food and Drug Administration
Published: 1990-04-26

Substantially Equivalent

Trimedyne, Inc.

FDA 510(k) clearance K895538 for ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY, Substantially Equivalent on 1990-04-26. Applicant: Trimedyne, Inc.. Device class: 2.

Clearance details

Applicant: Trimedyne, Inc.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-09-13
Decision date: 1990-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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