510(k) K854479
K854479 is an FDA 510(k) premarket notification submitted by Nipro Company, Ltd. for the device "BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH". The FDA issued a decision of Substantially Equivalent on Dec 16, 1985. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 1985
- Date Received
- Nov 7, 1985
- 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
- 510(k)