Clearance Summary
G.E.M. WATER SYSTEMS, INTERNATIONAL received FDA 510(k) clearance under submission number K970674, sponsored by G.E.M. Water Systems. 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 1997-11-19.
- Submission: K970674
- Applicant / Sponsor: G.E.M. Water Systems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1997-11-19
Classification & Regulation
This clearance is catalogued under FDA product code FIN and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.