FDA 510(k) Application Details - K152687

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

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510(K) Number K152687
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
Building 2, No. 202, Zhenzhong Road
West Lake Economy & Technology Zone
Hangzhou 310030 CN
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Contact Ren Yunhua
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/18/2015
Decision Date 10/16/2015
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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