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FDA 510(k) Application Details - K210435
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K210435
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.
North side of floor 3, BLD 9 BaiWangxin High-Tech
Industrial Park, Songbai Road
Shenzhen 518055 CN
Other 510(k) Applications for this Company
Contact
Aaron Lin
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
02/12/2021
Decision Date
05/12/2021
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
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