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FDA 510(k) Application Details - K111686
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K111686
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
A&D COMPANY, LTD.
1756 AUTOMATION PARKWAY
SAN JOSE, CA 9513 US
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Contact
JERRY WANG
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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
06/16/2011
Decision Date
08/01/2011
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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