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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K884087
Device Name HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact SANDRA L SCHICK
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact SANDRA L SCHICK
Classification Product Code
LOS
Date Received09/27/1988
Decision Date 02/23/1989
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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