CARESCAPE B650

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

GE Healthcare Finland Oy

The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Carescape B650.

Pre-market Notification Details

Device IDK191149
510k NumberK191149
Device Name:CARESCAPE B650
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki,  FI Fi-00510
ContactJoel Kent
CorrespondentJoel Kent
GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki,  FI Fi-00510
Product CodeMHX  
Subsequent Product CodeBZK
Subsequent Product CodeBZL
Subsequent Product CodeBZQ
Subsequent Product CodeCAP
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeCCL
Subsequent Product CodeDPS
Subsequent Product CodeDPZ
Subsequent Product CodeDQA
Subsequent Product CodeDQK
Subsequent Product CodeDRT
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXG
Subsequent Product CodeDXN
Subsequent Product Code&nb
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-30
Decision Date2020-01-21

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