OES ELITE Telescopes, Protective Tube— 510(k) K151191

Name: FDA 510(k) clearance K151191
Creator: U.S. Food and Drug Administration
Published: 2015-11-24

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K151191 for OES ELITE Telescopes, Protective Tube, Substantially Equivalent on 2015-11-24. Applicant: Olympus Winter & Ibe GmbH. Device class: 2.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code FBP
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2015-05-04
Decision date: 2015-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.