URONIRS, MODEL 2000— 510(k) K082701

Name: FDA 510(k) clearance K082701
Creator: U.S. Food and Drug Administration
Published: 2008-12-18

Substantially Equivalent

Urodynamix Technologies, Ltd.

FDA 510(k) clearance K082701 for URONIRS, MODEL 2000, Substantially Equivalent on 2008-12-18. Applicant: Urodynamix Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Urodynamix Technologies, Ltd.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 2008-09-16
Decision date: 2008-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver Bc, CA

Download summary PDF View on FDA.gov ↗

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