510(k) K142912
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2015
- Date Received
- October 6, 2014
- Clearance Type
- Abbreviated
- 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