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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
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