Panorama Patient Monitoring Network

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Shenzhen Mindray Bio-Medical Electronics Co.

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co. with the FDA for Panorama Patient Monitoring Network.

Pre-market Notification Details

Device IDK142601
510k NumberK142601
Device Name:Panorama Patient Monitoring Network
ClassificationMonitor, 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,  CN 518108
ContactDiane Arpino
CorrespondentDiane Arpino
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Bldg. 9-13, Baiwangxin High-Tech Industrial Park Biamang, Xili Town Nasham,  CN 518108
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-11
Decision Date2014-11-14
Summary:summary

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