Clearance Summary
SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM received FDA 510(k) clearance under submission number K915258, sponsored by Aqua-Med Systems, 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 1993-07-02.
- Submission: K915258
- Applicant / Sponsor: Aqua-Med Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 1993-07-02
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.