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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K895232
Device Name MODEL ELI-100/ST ELECTROCARDIOGRAPH
Applicant
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Applicant Contact M SCHUELLER
Correspondent
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Correspondent Contact M SCHUELLER
Classification Product Code
LOS
Date Received08/21/1989
Decision Date 12/13/1989
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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