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FDA 510(k) Application Details - K032346
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K032346
Device Name
System,Network And Communication,Physiological Monitors
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact
DIANA M THORSON
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Regulation Number
870.2300
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Classification Product Code
MSX
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More FDA Info for this Product Code
Date Received
07/30/2003
Decision Date
08/05/2003
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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