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FDA 510(k) Application Details - K060504
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K060504
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
IDEAL LIFE INC.
1220 19TH STREET N.W.
SUITE 300
WASHINGTON, DC 20036 US
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Contact
DIANE MANDELL
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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
02/27/2006
Decision Date
03/14/2006
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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