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 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	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