FDA 510(k) Application Details - K232816

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K232816
Device Name	Electrocardiograph
Applicant	Shenzhen Le Medical Technology Co., Ltd. 5F, Block A, XinYongFeng Industrial Park, No.2 Tianbao Road, YinRenShi Community, ShiYanSub Shenzhen 518108 CN Other 510(k) Applications for this Company
Contact	Wuyaxiong . Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2023
Decision Date	06/07/2024
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