FDA 510(k) Application Details - K031487

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

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510(K) Number K031487
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS, MN 55447-4755 US
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Contact RICHARD P BENNETT
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 05/12/2003
Decision Date 03/22/2004
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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