510(k) K003058
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2001
- Date Received
- October 2, 2000
- 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