FDA 510(k) Application Details - K160530

Device Classification Name Blood Pressure Cuff

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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
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Regulation Number 870.1120

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Classification Product Code DXQ
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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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