FDA 510(k) Application Details - K134029

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K134029
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
702, 704 BLOCK C, TSINGHUA UNIS SCIENCE PARK
NO. 13 LANGSHAN RD HI-TECH IND
SHENZHEN, GUANGDONG 518057 CN
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Contact PANG MING
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/31/2013
Decision Date 07/25/2014
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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