FDA 510(k) Application Details - K143432

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K143432
Device Name	Electrocardiograph
Applicant	CARDIO-PHOENIX INC. 2102-65 SPRING GARDEN AVE TORONTO M2N 6H9 CA Other 510(k) Applications for this Company
Contact	MARC BISNAIRE 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	12/01/2014
Decision Date	06/03/2015
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