FDA 510(k) Application Details - K240756

Device Classification Name	More FDA Info for this Device
510(K) Number	K240756
Device Name	AITRICS-VC
Applicant	AITRICS Co.,Ltd. 13F, 218, Teheran-ro, Gangnam-gu Seoul 06221 KR Other 510(k) Applications for this Company
Contact	Dongyeop Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2024
Decision Date	07/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review