FDA 510(k) Application Details - K023286

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

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510(K) Number K023286
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant NEPTEC DESIGN GROUP, LTD.
302 LEGGET DR.
KANATA, ONTARIO K2K 1Y5 CA
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Contact JOHN SCHNEIDER
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 10/02/2002
Decision Date 05/02/2003
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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