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FDA 510(k) Application Details - K071982
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K071982
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact
LISA M BAUMHARDT
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/19/2007
Decision Date
09/21/2007
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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