FDA 510(k) Application Details - K143195

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K143195
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Mindray Building, Keji 12th Road South Hi-tech Industrial Park Shenzhen 518057 TW Other 510(k) Applications for this Company
Contact	Yanhong Bai 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	11/06/2014
Decision Date	12/22/2014
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