FDA 510(k) Application Details - K182631

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K182631
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	Eurogreen International Inc. No. 48, Lane 220, Sec. 1, Fu-Zun Rd., Yuan-Lin Township Chang-Hua County 51055 CN Other 510(k) Applications for this Company
Contact	David Hsieh Other 510(k) Applications for this Contact
Regulation Number	890.3800   More FDA Info for this Regulation Number
Classification Product Code	INI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2018
Decision Date	09/19/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review