FDA 510(k) Application Details - K990638

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

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510(K) Number K990638
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant GENMED, INC.
914 WEST PATAPSCO AVE.
BALTIMORE, MD 21230-3432 US
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Contact EDWARD HYER
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 02/26/1999
Decision Date 10/07/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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