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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 K122073
Device Name ELI 280 ELECTROCARDIOGRAPH
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224
Applicant Contact AMY YANG
Correspondent
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224
Correspondent Contact AMY YANG
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/16/2012
Decision Date 08/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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