FDA 510(k) Application Details - K230292

Device Classification Name	More FDA Info for this Device
510(K) Number	K230292
Device Name	Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
Applicant	Samsung Electronics Co., Ltd 129 Samsung-ro, Yeoungton-gu Suwon-si KR Other 510(k) Applications for this Company
Contact	Hon Pak 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	02/02/2023
Decision Date	05/02/2023
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