Patient Monitor

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 Patient Monitor.

Pre-market Notification Details

Device IDK192972
510k NumberK192972
Device Name:Patient Monitor
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road SoutH Hi-tech Industrial Park, Nanshan Shenzhen,  CN 518057
ContactYanhong Bai
CorrespondentYanhong Bai
Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road SoutH Hi-tech Industrial Park, Nanshan Shenzhen,  CN 518057
Product CodeMHX  
Subsequent Product CodeDQA
Subsequent Product CodeDRT
Subsequent Product CodeDSI
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-24
Decision Date2020-05-07

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