FDA 510(k) Application Details - K110809

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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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
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Regulation Number 870.2910

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Classification Product Code DRG
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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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