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FDA 510(k) Application Details - K130584
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K130584
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
CASARSA ROBERT
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Regulation Number
870.1025
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Classification Product Code
MHX
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More FDA Info for this Product Code
Date Received
03/05/2013
Decision Date
06/26/2013
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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