510(k) K781461
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1978
- Date Received
- August 18, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Photic, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1890
- Review Panel
- NE
- Submission Type