IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS

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

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Imec, Ipm And Beneview T1 Patient Monitors.

Pre-market Notification Details

Device IDK123074
510k NumberK123074
Device Name:IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck,  NY  11021
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-01
Decision Date2013-07-03
Summary:summary

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