FDA 510(k) Application Details - K151290

Device Classification Name Blood Pressure Cuff

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510(K) Number K151290
Device Name Blood Pressure Cuff
Applicant XUZHOU MAICUFF TECHNOLOGY CO.,LTD.
8#-2-1106, JINXIUJIAYUAN, JIANGUO WEST ROAD
XUZHOU 221006 CN
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Contact LI ZHAOQIAN
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 05/15/2015
Decision Date 06/30/2015
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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