FDA 510(k) Application Details - K980495

Device Classification Name System, Ecg Analysis

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510(K) Number K980495
Device Name System, Ecg Analysis
Applicant MARQUETTE MEDICAL SYSTEMS, INC.
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact KRISTIN PABST
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Regulation Number 000.0000

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Classification Product Code LOS
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Date Received 02/09/1998
Decision Date 05/07/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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