FDA 510(k) Application Details - K120598

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

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510(K) Number K120598
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS CHINA CO., LTD.
8200 WEST TOWER AVE
MILWAUKEE, WI 53223 US
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Contact ROBERT CASARSA
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 02/28/2012
Decision Date 07/19/2012
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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