FDA 510(k) Application Details - K170568

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K170568
Device Name	Electrocardiograph
Applicant	Cardiologs Technologies 15 rue I'Ecole de Medecine Paris 75006 FR Other 510(k) Applications for this Company
Contact	Quentin de Snoeck Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2017
Decision Date	06/26/2017
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