510(k) K910656
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1991
- Date Received
- February 14, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Station, Dialysis Control, Negative Pressure Type
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type