FDA 510(k) Application Details - K002209

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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510(K) Number K002209
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact KRISTIN PABST
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 07/21/2000
Decision Date 08/18/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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