Clearance Summary
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 received FDA 510(k) clearance under submission number K043436, sponsored by Nxstage Medical, 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 2005-03-17.
- Submission: K043436
- Applicant / Sponsor: Nxstage Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2005-03-17
Classification & Regulation
This clearance is catalogued under FDA product code FKR and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.