BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)

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 Benevision N Series Patient Monitors (including Benevision N12, Benevision N15, Benevision N17, Benevision N19. Benevision N22, Benevision N1).

Pre-market Notification Details

Device IDK182075
510k NumberK182075
Device Name:BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
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,  TW 518057
ContactYanhong Bai
CorrespondentYanhong Bai
Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen,  TW 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 Received2018-08-01
Decision Date2018-12-10
Summary:summary

NIH GUDID Devices

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