510(k) K162086
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2017
- Date Received
- July 27, 2016
- Clearance Type
- Traditional
- 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