FDA 510(k) Application Details - K191106

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K191106
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	Shenzhen Comen Medical Instruments Co.,Ltd. Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 To Floor 5 of Building 2, FIYTA Timepiece Bldg, Nanhuan Ave. Shenzhen 518106 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	04/25/2019
Decision Date	12/13/2019
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