510(k) K062478
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2007
- Date Received
- August 24, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 868.2775
- Review Panel
- AN
- Submission Type