FDA 510(k) Application Details - K240991

Device Classification Name	More FDA Info for this Device
510(K) Number	K240991
Device Name	eMVFit (MVF-10M)
Applicant	Weero Co., Ltd. A-605, Venture Valley II, 142-10, Saneop-Ro 156 Beon-Gil Gwonseon-Gu Suwon-Si Suwon 16648 KR Other 510(k) Applications for this Company
Contact	Moon young 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	04/11/2024
Decision Date	10/09/2024
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