FDA 510(k) Application Details - K032825

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

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510(K) Number K032825
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MARS MEDICAL PRODUCTS CO., LTD.
1676 VILLAGE GREEN SUITE A
CROFTON, MD 21114-4341 US
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Contact E.J. Smith
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/10/2003
Decision Date 12/10/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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