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FDA 510(k) Application Details - K100553
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K100553
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
CITIZEN SYSTEMS JAPAN CO., LTD.
3000 K STREET NW
SUITE 600
WASHINGTON, DC 20007-5143 US
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Contact
NATHAN A BEAVER
Other 510(k) Applications for this Contact
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
02/26/2010
Decision Date
05/25/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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