FDA 510(k) Application Details - K041778

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

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510(K) Number K041778
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MAXI-AIDS, INC.
42 EXECUTIVE BLVD.
FARMINGDALE, NY 11735 US
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Contact ELLIOT ZARETSKY
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 07/01/2004
Decision Date 08/31/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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