510(k) K844850
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 1985
- Date Received
- December 13, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Dialysate Delivery, Central Multiple Patient
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type