510(k) K802831
K802831 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO PERITONEAL DIALYSIS MONITOR". The FDA issued a decision of Substantially Equivalent on Dec 18, 1980. The device falls under product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal), a Class II device regulated under 21 CFR 876.5630. Gambro, Inc. has 86 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 18, 1980
- Date Received
- Nov 12, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Dialysate Delivery, Semi-Automatic, Peritoneal
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
- 510(k)