FDA 510(k) Application Details - K991014

Device Classification Name System, Ecg Analysis

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510(K) Number K991014
Device Name System, Ecg Analysis
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact LAURA L MCCOMIS
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Regulation Number 000.0000

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Classification Product Code LOS
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Date Received 03/26/1999
Decision Date 10/20/1999
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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