510(k) K192958
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 2020
- Date Received
- October 22, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Peripheral, Electric
- Device Class
- Class II
- Regulation Number
- 868.2775
- Review Panel
- AN
- Submission Type