Monitor B125, Monitor B105

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

GE Medical Systems Information Technologies, Inc.

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Monitor B125, Monitor B105.

Pre-market Notification Details

Device IDK201941
510k NumberK201941
Device Name:Monitor B125, Monitor B105
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee,  WI  53223
ContactJoel Kent
CorrespondentJoel Kent
GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee,  WI  53223
Product CodeMHX  
Subsequent Product CodeBZQ
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDPZ
Subsequent Product CodeDQA
Subsequent Product CodeDQK
Subsequent Product CodeDRT
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeGWQ
Subsequent Product CodeKRB
Subsequent Product CodeMLD
Subsequent Product CodeNHO
Subsequent Product Code&nb
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-13
Decision Date2020-11-04

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