FDA 510(k) Application Details - K182790

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K182790
Device Name	Electrocardiograph
Applicant	Cardio-Phoenix Inc. 44 Rosemead Close Markham L3R 3Z3 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	10/01/2018
Decision Date	12/14/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review