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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K882818
Device Name SEER
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact THOMAS MASSOPUST
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact THOMAS MASSOPUST
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/08/1988
Decision Date 06/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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