FDA 510(k) Application Details - K980845

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

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510(K) Number K980845
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MARS MEDICAL PRODUCTS
P.O. BOX 4341
CROFTON, MD 21114 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 03/04/1998
Decision Date 12/14/1998
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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