FDA 510(k) Application Details - K191209

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K191209
Device Name	Blood Pressure Cuff
Applicant	Dongguan Mars Medical Products Co., Ltd 381, Manfeng West Road, Manfeng Group Dani Village, Shatian Town, Dongguan Cit 523993 CN Other 510(k) Applications for this Company
Contact	Lily Liao 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	05/06/2019
Decision Date	06/18/2019
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