FDA 510(k) Application Details - K123095

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K123095
Device Name Transducer, Blood-Pressure, Extravascular
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact MATT CLAUSEN
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 10/02/2012
Decision Date 05/08/2013
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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