Clearance Summary
Nelson Sentinel Series Basic Chlorine Sentinel received FDA 510(k) clearance under submission number K193169, sponsored by Nelson Environmental 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 2020-10-29.
- Submission: K193169
- Applicant / Sponsor: Nelson Environmental Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2020-10-29
Classification & Regulation
This clearance is catalogued under FDA product code MSY and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.