FDA 510(k) Application Details - K242623

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K242623
Device Name	Blood Pressure Cuff
Applicant	Shenzhen Medke Technology Co., Ltd. 401, 503, Bldg. A1, Anle Ind. Zone No. 172, Hangcheng RD. Sanwei Community, Hangcheng Street Baoan District Shenzhen 518126 CN Other 510(k) Applications for this Company
Contact	Wei Tao Li Other 510(k) Applications for this Contact
Regulation Number	870.1120   More FDA Info for this Regulation Number
Classification Product Code	DXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2024
Decision Date	10/31/2024
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