FDA 510(k) Application Details - K961139

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K961139
Device Name Detector And Alarm, Arrhythmia
Applicant MARQUETTE ELECTRONICS, INC.
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact DIANNE SCHMITZ
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 03/21/1996
Decision Date 08/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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