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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 K093339
Device Name ELI PC ELECTROCARDIOGRAPH
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224
Applicant Contact CHARLES MORREALE
Correspondent
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224
Correspondent Contact CHARLES MORREALE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/26/2009
Decision Date 02/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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