510(k) K043239
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2004
- Date Received
- November 23, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type