FDA 510(k) Application Details - K093739

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

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510(K) Number K093739
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant NINGBO DIAIER ELECTRONIC CO., LTD.
YAOXI INDUSTRIAL ZONE
YUYAO CITY, ZHEJIANG CN
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Contact LAO XIKUN
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/04/2009
Decision Date 05/07/2010
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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