FDA 510(k) Application Details - K092719

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

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510(K) Number K092719
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD
NO.8 TONGXING ROAD, NANTONG
ECONOMIC& TECH DEVELOPMENT
NANTONG, JIANGSU 226007 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 09/03/2009
Decision Date 09/18/2009
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 Y
Expedited Review



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