510(k) K850538
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1985
- Date Received
- February 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alarm, Conditioned Response Enuresis
- Device Class
- Class II
- Regulation Number
- 876.2040
- Review Panel
- GU
- Submission Type