Clearance Summary
WATER PURIFICATION SYSTEM received FDA 510(k) clearance under submission number K994292, sponsored by Water & Power Technologies, Inc.. 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 2001-01-02.
- Submission: K994292
- Applicant / Sponsor: Water & Power Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2001-01-02
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.