510(k) K913604
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1991
- Date Received
- August 14, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Mechanical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1880
- Review Panel
- NE
- Submission Type