FDA 510(k) Application Details - K142601

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K142601
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	Shenzhen Mindray Bio-Medical Electronics Co. Bldg. 9-13 , Baiwangxin High-Tech Industrial Park Biamang, Xili Town Nasham 518108 CN Other 510(k) Applications for this Company
Contact	Diane Arpino 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	09/11/2014
Decision Date	11/14/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review