FDA 510(k) Application Details - K160092

Device Classification Name Electrocardiograph

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510(K) Number K160092
Device Name Electrocardiograph
Applicant SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
#A735,Shenzhen Mingyou Industrial Product
Exhibition & Procurement Center,
Shenzhen 518102 CN
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Contact Hongbo Zhong
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 01/15/2016
Decision Date 02/12/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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