Clearance Summary
PHOENIX 5 URODYNAMICS SYSTEM received FDA 510(k) clearance under submission number K914300, sponsored by Aspen Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1992-06-02.
- Submission: K914300
- Applicant / Sponsor: Aspen Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 1992-06-02
Classification & Regulation
This clearance is catalogued under FDA product code FAP and 21 CFR 876.1620, within the Gastroenterology, Urology review panel as a Class II device.