510(k) K941599
Clearance Details
- Decision
- SN ()
- Decision Date
- October 24, 1995
- Date Received
- April 1, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Dialysate Ph Indicator
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type