FDA 510(k) Application Details - K212253

Device Classification Name	More FDA Info for this Device
510(K) Number	K212253
Device Name	Apollo Duet (Model : APD-4000)
Applicant	Weero Co. A605 Venture Valley II, 142-10, Saneop-ro 156 beon-gil Gwonseon-gu Suwon-si 16648 KR Other 510(k) Applications for this Company
Contact	Jimin Han Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2021
Decision Date	08/25/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review