Clearance Summary
BICARB MIXING AND DISTRIBUTION SYSTEM received FDA 510(k) clearance under submission number K112427, sponsored by Isopure, Corp.. 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 2012-01-26.
- Submission: K112427
- Applicant / Sponsor: Isopure, Corp.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2012-01-26
Classification & Regulation
This clearance is catalogued under FDA product code FIN and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.