FDA 510(k) Application Details - K131463

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

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510(K) Number K131463
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant HONSUN (NANTONG) CO., LTD
NO.8, TONGXING ROAD
JIANGSU 226009 CN
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Contact SELINA QIAN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 05/21/2013
Decision Date 07/08/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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