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FDA 510(k) Application Details - K110809
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K110809
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
CAREFUSION 303, INC.
115 MITON PARK
BUILDING 3
ABINGDON,OXON OX 14 4RZ GB
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Contact
SIMON PEARMAIN
Other 510(k) Applications for this Contact
Regulation Number
870.2910
More FDA Info for this Regulation Number
Classification Product Code
DRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/23/2011
Decision Date
07/05/2011
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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