510(k) K033253
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2003
- Date Received
- October 8, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type