FDA 510(k) Application Details - K182018

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

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510(K) Number K182018
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant Shenzhen Kingyield Technology Co., Ltd.
Section C2, Fuhai Industrial Zone, Fuyong Town,
Baoan District
Shenzhen 518000 CN
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Contact Dacheng Gong
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 07/27/2018
Decision Date 10/06/2018
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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