Clearance Summary
HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL received FDA 510(k) clearance under submission number K904967, sponsored by Gambro-Hosp-Cobe, 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 1991-01-28.
- Submission: K904967
- Applicant / Sponsor: Gambro-Hosp-Cobe, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1991-01-28
Classification & Regulation
This clearance is catalogued under FDA product code FKP and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.