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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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DAVID LEE
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Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
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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