LUX-Dx Insertable Cardiac Monitor, MyLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US

Detector And Alarm, Arrhythmia

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Lux-dx Insertable Cardiac Monitor, Mylux Software Mobile Application, Lux-dx Clinic Assistant Software, Application Server Device Services (ds) - Us.

Pre-market Notification Details

Device IDK193473
510k NumberK193473
Device Name:LUX-Dx Insertable Cardiac Monitor, MyLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
ClassificationDetector And Alarm, Arrhythmia
Applicant Boston Scientific Corporation 4100 Hamline Ave North St. Paul,  MN  55112
ContactMelissa Klamerus
CorrespondentMelissa Klamerus
Boston Scientific Corporation 4100 Hamline Ave North St. Paul,  MN  55112
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-16
Decision Date2020-06-26

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