Clearance Summary
MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis received FDA 510(k) clearance under submission number K153329, sponsored by Med-Tech Water 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 2016-08-04.
- Submission: K153329
- Applicant / Sponsor: Med-Tech Water Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2016-08-04
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.