FDA 510(k) Application Details - K083681

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

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510(K) Number K083681
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant BIOLAND TECHNOLOGY LTD.
BLK C, G/F, MING CT.,
19-23 MING YUEN W. ST.
NORTH POINT HK
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Contact DAVID LEE
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/12/2008
Decision Date 01/16/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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