Clearance Summary
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 received FDA 510(k) clearance under submission number K101715, sponsored by Fresenius Medical Care North America, Design Cente. 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 2010-12-21.
- Submission: K101715
- Applicant / Sponsor: Fresenius Medical Care North America, Design Cente
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2010-12-21
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.