510(k) K012258
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2001
- Date Received
- July 18, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vehicle, Motorized 3-Wheeled
- Device Class
- Class II
- Regulation Number
- 890.3800
- Review Panel
- PM
- Submission Type