510(k) K830345
K830345 is an FDA 510(k) premarket notification submitted by Amigo Sales, Inc. for the device "SCOOTER, VEHICLE MOTORIZED". The FDA issued a decision of Substantially Equivalent on March 10, 1983. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Amigo Sales, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1983
- Date Received
- January 28, 1983
- 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