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FDA 510(k) Application Details - K162432
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K162432
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
CAREFUSION 2200 INC.
75 NORTH FAIRWAY DRIVE
VERNON HILLS, IL 60061 US
Other 510(k) Applications for this Company
Contact
ERIKA FERNANDEZ
Other 510(k) Applications for this Contact
Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2016
Decision Date
01/18/2017
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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