FDA 510(k) Application Details - K123800

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

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510(K) Number K123800
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD.
No. 8, Tongxing Road, Nantong Economic &
Technological Development Area
Nantong 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 12/10/2012
Decision Date 05/15/2013
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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