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FDA 510(k) Application Details - K170605
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K170605
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd
Yunyang Industrial Park
Danyang, Jiangsu
Danyang 212300 CN
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Contact
Rong Zhong
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
03/01/2017
Decision Date
03/27/2018
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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