CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045— 510(k) K080613

Name: FDA 510(k) clearance K080613
Creator: U.S. Food and Drug Administration
Published: 2008-11-06

Substantially Equivalent

Minimally Invasive Devices, LLC

FDA 510(k) clearance K080613 for CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045, Substantially Equivalent on 2008-11-06. Applicant: Minimally Invasive Devices, LLC. Device class: 2.

Clearance details

Applicant: Minimally Invasive Devices, LLC
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2008-03-04
Decision date: 2008-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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