FDA 510(k) Application Details - K021470

Device Classification Name Electrocardiograph,Ambulatory(Without Analysis)

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510(K) Number K021470
Device Name Electrocardiograph,Ambulatory(Without Analysis)
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact LISA LEE MICHELS
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Regulation Number 870.2800

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Classification Product Code MWJ
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Date Received 05/08/2002
Decision Date 11/14/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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