FDA 510(k) Application Details - K103715

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K103715
Device Name Transducer, Blood-Pressure, Extravascular
Applicant MIRADOR BIOMEDICAL, INC.
2815 WASTLAKE AVENUE
SUITE 300
SEATTLE, WA 98102 US
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Contact JUSTIN HULVERSHORN
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 12/21/2010
Decision Date 01/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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