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FDA 510(k) Application Details - K161577
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K161577
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
Building 2, No. 202, Zhenzhong Road
West Lake Economy & Technology Zone
Hang zhou 310030 CN
Other 510(k) Applications for this Company
Contact
Ren Yunhua
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
06/07/2016
Decision Date
02/08/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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