Clearance Summary
GR100F URINE FLOWMETER received FDA 510(k) clearance under submission number K971913, sponsored by Albyn 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 1997-09-19.
- Submission: K971913
- Applicant / Sponsor: Albyn Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1800
- Decision date: 1997-09-19
Classification & Regulation
This clearance is catalogued under FDA product code EXY and 21 CFR 876.1800, within the Gastroenterology, Urology review panel as a Class II device.