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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K120865
Device Name RSCRIBE ELECTROCARDIOGRAPH
Original Applicant
MORTARA INSTRUMENT, INC
7865 north 86th street
milwaukee,  WI  53224
Original Contact charles morreale
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/22/2012
Decision Date 07/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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