Passport Series Patient Monitors (including Passport 17m, Passport 12m And T1)

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 Passport Series Patient Monitors (including Passport 17m, Passport 12m And T1).

Pre-market Notification Details

Device IDK190011
510k NumberK190011
Device Name:Passport Series Patient Monitors (including Passport 17m, Passport 12m And T1)
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 Received2019-01-03
Decision Date2019-07-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904028712 K190011 000
06944904096780 K190011 000
06936415919054 K190011 000
06936415919092 K190011 000
06936415919122 K190011 000
06936415902360 K190011 000
06936415902650 K190011 000
06936415902681 K190011 000
06936415902711 K190011 000
06944904096636 K190011 000
06944904096735 K190011 000
06944904096742 K190011 000
06944904096773 K190011 000
06944904096728 K190011 000

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