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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 K142105
Device Name ELI 380 ELECTROCARDIOGRAPH
Applicant
MORTARA INSTRUMENT, INC
7865 NORTH 86TH STREET
MILWAUKEE,  WI  53224
Applicant Contact AMY YANG
Correspondent
MORTARA INSTRUMENT, INC
7865 NORTH 86TH STREET
MILWAUKEE,  WI  53224
Correspondent Contact AMY YANG
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/01/2014
Decision Date 09/05/2014
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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