FDA 510(k) Application Details - K111141

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

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510(K) Number K111141
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant WENZHOU BOKANG INSTRUMENTS CO., LTD.
HAINING ROAD, HAIBIN LONGWAN
WENZHOU, ZHEJIANG P.R. 325024 CN
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Contact JOHNNY CAO
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 04/22/2011
Decision Date 02/21/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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