510(k) K991132
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1999
- Date Received
- April 2, 1999
- 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