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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K974199
Device Name ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
Applicant
Marquette Medical Systems, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact KRISTIN PABST
Correspondent
Marquette Medical Systems, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact KRISTIN PABST
Classification Product Code
LOS
Date Received11/10/1997
Decision Date 02/06/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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