Clearance Summary
ACCUMETER ELECTRONIC URINEMETER SYSTEM received FDA 510(k) clearance under submission number K844030, sponsored by Travenol Laboratories, S.A.. 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 1984-11-20.
- Submission: K844030
- Applicant / Sponsor: Travenol Laboratories, S.A.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1800
- Decision date: 1984-11-20
Classification & Regulation
This clearance is catalogued under FDA product code FFG and 21 CFR 876.1800, within the Gastroenterology, Urology review panel as a Class II device.