FDA 510(k) Application Details - K973613

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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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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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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