FDA 510(k) Application Details - K201168

Device Classification Name	More FDA Info for this Device
510(K) Number	K201168
Device Name	ECG Monitor App
Applicant	Samsung Electronics Co., Ltd 129, Samsung-ro, Yeongtong-gu, Suwon-si 16677 KR Other 510(k) Applications for this Company
Contact	Taejong Jay Yang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2020
Decision Date	08/04/2020
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