510(k) K931574
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1993
- Date Received
- March 30, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cystometer, Electrical Recording
- Device Class
- Class II
- Regulation Number
- 876.1620
- Review Panel
- GU
- Submission Type