FDA 510(k) Application Details - K160840

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K160840
Device Name	Electrocardiograph
Applicant	CARDIOLINE S.p.A VIA LINZ 19/20/21 SPINI DI GARDOLO 38121 IT Other 510(k) Applications for this Company
Contact	EMANUELE ERCOLI 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	03/28/2016
Decision Date	08/12/2016
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