Clearance Summary
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM received FDA 510(k) clearance under submission number K981085, sponsored by Gambro Healthcare. 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 1998-05-18.
- Submission: K981085
- Applicant / Sponsor: Gambro Healthcare
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 1998-05-18
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.