FDA 510(k) Application Details - K202336

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K202336
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Alice Yang 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	08/17/2020
Decision Date	01/23/2021
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