MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22— 510(k) K080550

Name: FDA 510(k) clearance K080550
Creator: U.S. Food and Drug Administration
Published: 2008-06-10

Substantially Equivalent

Minos Medical

FDA 510(k) clearance K080550 for MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22, Substantially Equivalent on 2008-06-10. Applicant: Minos Medical. Device class: 2.

Clearance details

Applicant: Minos Medical
Product code: Code ODB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2008-02-28
Decision date: 2008-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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