510(k) K040074
K040074 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "ONEVIEW INTERFACE". The FDA issued a decision of Substantially Equivalent on April 8, 2004. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2004
- Date Received
- January 14, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Dialysate Delivery, Single Patient
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type