FDA 510(k) Application Details - K021454

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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510(K) Number K021454
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact JOELLE NEIDER
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 05/06/2002
Decision Date 10/01/2002
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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