Clearance Summary
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT received FDA 510(k) clearance under submission number K133807, sponsored by Gambro Renal Products, 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 2014-03-26.
- Submission: K133807
- Applicant / Sponsor: Gambro Renal Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5870
- Decision date: 2014-03-26
Classification & Regulation
This clearance is catalogued under FDA product code FLD and 21 CFR 876.5870, within the Gastroenterology, Urology review panel as a Class II device.