URONIRS, MODEL 2000— 510(k) K082701

Substantially Equivalent

Urodynamix Technologies, Ltd.

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

Clearance details

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

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