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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, blood-pressure, extravascular
510(k) Number K133624
Device Name COMPASS CT, COMPASS CT PORT
Applicant
MIRADOR BIOMEDICAL
2815 EASTLAKE AVE E SUITE 220
SEATTLE,  WA  98102
Applicant Contact JUSTIN HULVERSHORN
Correspondent
MIRADOR BIOMEDICAL
2815 EASTLAKE AVE E SUITE 220
SEATTLE,  WA  98102
Correspondent Contact JUSTIN HULVERSHORN
Regulation Number870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXG  
Date Received11/26/2013
Decision Date 04/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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