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FDA 510(k) Application Details - K122253
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K122253
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
Other 510(k) Applications for this Contact
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
07/27/2012
Decision Date
03/22/2013
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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