Clearance Summary
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM received FDA 510(k) clearance under submission number K133149, sponsored by Mar Cor Purification, 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 2014-04-30.
- Submission: K133149
- Applicant / Sponsor: Mar Cor Purification, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2014-04-30
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.