FDA 510(k) Application Details - K101685

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K101685
Device Name	Electrode, Electrocardiograph
Applicant	INTEGRAL PROCESS SAS 12 RUE DES CAYENNES PB 310 CONFLANS SAINTE HONORINE 78703 FR Other 510(k) Applications for this Company
Contact	CHRISTIAN BERTHON Other 510(k) Applications for this Contact
Regulation Number	870.2360   More FDA Info for this Regulation Number
Classification Product Code	DRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2010
Decision Date	07/01/2010
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	Y
Expedited Review