510(k) K871338
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1987
- Date Received
- April 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type