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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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More FDA Info for this Product Code
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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