PHOENIX 5 URODYNAMICS SYSTEM— 510(k) K914300

Name: FDA 510(k) clearance K914300
Creator: U.S. Food and Drug Administration
Published: 1992-06-02

Substantially Equivalent

Aspen Medical , Ltd.

FDA 510(k) clearance K914300 for PHOENIX 5 URODYNAMICS SYSTEM, Substantially Equivalent on 1992-06-02. Applicant: Aspen Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Aspen Medical , Ltd.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1991-09-25
Decision date: 1992-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scotland, GB

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