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FDA 510(k) Application Details - K160530
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K160530
Device Name
Blood Pressure Cuff
Applicant
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
4TH FL, BLDG A, YINGTAILONG INDUSTRIAL PRK,
DALANG SOUTH ROAD, LONGHUA DISTRICT
Shenzhen 518109 CN
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Contact
Mina Cheng
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
02/25/2016
Decision Date
11/28/2016
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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