FDA 510(k) Application Details - K180335

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K180335
Device Name	Blood Pressure Cuff
Applicant	Shanghai Hulu Devices Co., Ltd No. 509 Caobao Road, Room 101-2 Bld 9, Xuhui District Shanghai CN Other 510(k) Applications for this Company
Contact	Junfeng Zhao 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	02/06/2018
Decision Date	03/08/2018
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	Y
Expedited Review