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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 K152944
Device Name Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH STREET
MILWAUKEE,  WI  53224
Applicant Contact ELEANORE DIAS
Correspondent
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH STREET
MILWAUKEE,  WI  53224
Correspondent Contact ELEANORE DIAS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/06/2015
Decision Date 01/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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