FDA 510(k) Application Details - K243118

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K243118
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Shenzhen IMDK Medical Technology Co., Ltd. 904, 9F, Guangming Tianan Cloud Park Building, 255 Zhenmei Road Zhenmei Community, Xinhu Street, Guangming District Shenzhen 518107 CN Other 510(k) Applications for this Company
Contact	Yuan Xia Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	11/26/2024
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