Clearance Summary
SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS received FDA 510(k) clearance under submission number K894300, sponsored by U.S. Filter/Continental 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 1990-03-13.
- Submission: K894300
- Applicant / Sponsor: U.S. Filter/Continental Water Systems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 1990-03-13
Classification & Regulation
This clearance is catalogued under FDA product code FIP and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.