FDA 510(k) Application Details - K211619

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K211619
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	Shenzhen Comen Medical Instruments CO., LTD. FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-District, Guangming District Shenzhen 51806 CN Other 510(k) Applications for this Company
Contact	Hongbo Yan Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2021
Decision Date	12/29/2022
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