FDA 510(k) Application Details - K171580

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K171580
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	GE MEDICAL SYSTEMS (CHINA) CO., LTD. No. 19 Changjiang road National Hi-Tech Dev. Zone WuXi 214028 CN Other 510(k) Applications for this Company
Contact	Sun YanLi 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	05/31/2017
Decision Date	11/01/2017
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