FDA 510(k) Application Details - K202464

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K202464
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	Xandar Kardian Inc. #309, Seongsuil-Ro 10-Gil Seongdong-gu Seoul 04793 KR Other 510(k) Applications for this Company
Contact	Glen (Jeong Woo) Choi Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	DRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2020
Decision Date	04/26/2021
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