Clearance Summary
Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand received FDA 510(k) clearance under submission number K182164, sponsored by Ecolab, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-03-29.
- Submission: K182164
- Applicant / Sponsor: Ecolab, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2019-03-29
Classification & Regulation
This clearance is catalogued under FDA product code NHV and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.