510(k) K954278
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1995
- Date Received
- September 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Cystometric, Electric
- Device Class
- Class II
- Regulation Number
- 876.4890
- Review Panel
- GU
- Submission Type