FDA 510(k) Application Details - K151810

Device Classification Name Blood Pressure Cuff

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510(K) Number K151810
Device Name Blood Pressure Cuff
Applicant SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
2/F, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE
HI-TECH INDUSTRIAL PARK
NANSHAN DISTRICT, SHENZHEN 518057 CN
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Contact XIE QIONGYU
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 07/02/2015
Decision Date 12/17/2015
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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