510(k) K030470
K030470 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NXSTAGE SYSTEM ONE". The FDA issued a decision of Substantially Equivalent on July 7, 2003. The device falls under product code FII (System, Dialysate Delivery, Sealed), a Class II device regulated under 21 CFR 876.5860. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2003
- Date Received
- February 12, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Dialysate Delivery, Sealed
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type