FDA 510(k) Application Details - K162768

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K162768
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	INTEGRAL PROCESS SAS 12 RUE DES CAYENNES PO BOX BP 20310 CONFLANS SAINTE HONORINE 78703 FR Other 510(k) Applications for this Company
Contact	Virginie S Grondin 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	09/30/2016
Decision Date	08/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review