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FDA 510(k) Application Details - K162616
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K162616
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Xuzhou Yongkang Electronic Science Technology Co., Ltd
4F Building C8,40 Jingshan Road
Econonic and Technolgical Development Zone
Xuzhou 102628 CN
Other 510(k) Applications for this Company
Contact
YanLi Li
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
09/20/2016
Decision Date
03/09/2018
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
N
Expedited Review
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