FDA 510(k) Application Details - K152472

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K152472
Device Name Transducer, Blood-Pressure, Extravascular
Applicant ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
305#TANGGONG ROAD, PAOJIANG INDUSTRIAL ZONE
SHAOXING 312071 CN
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Contact Junbin Hu
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 08/31/2015
Decision Date 10/31/2016
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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