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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K161465
Device Name CardioConfirm
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH STREET
milwaukee,  WI  53224
Applicant Contact margaret mucha
Correspondent
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH STREET
milwaukee,  WI  53224
Correspondent Contact margaret mucha
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received05/27/2016
Decision Date 09/03/2016
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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