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FDA 510(k) Application Details - K163316
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K163316
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
CAREFUSION 303, INC.
75 N Fairway Drive
Vernon Hills, IL 60061 US
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Contact
Erika Fernandez
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Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
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More FDA Info for this Product Code
Date Received
11/23/2016
Decision Date
06/22/2017
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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