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FDA 510(k) Application Details - K973613
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K973613
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
FOLEY & LARDNER
3000 K STREET, N.W.
SUITE 500
WASHINGTON, DC 20007-5109 US
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Contact
JOSEPH D EDMONDSON JR.
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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
09/22/1997
Decision Date
04/14/1998
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
N
Expedited Review
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