510(k) K003260
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2001
- Date Received
- October 18, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type