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FDA 510(k) Application Details - K112270
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K112270
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
ACCUMED HEALTHCARE (SHANGHAI) INC.
P.O. BOX 1277
MAPLE VALLEY, WA 98038 US
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Contact
CYNTHIA (CINDY) GREEN
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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
08/08/2011
Decision Date
11/22/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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