510(k) K023525
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2004
- Date Received
- October 21, 2002
- Clearance Type
- Abbreviated
- 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