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510(k) Data Aggregation

K Number

Device Name

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)

Manufacturer

Boston Scientific Corporation

Date Cleared

2025-09-12

(28 days)

Product Code

Regulation Number

Type

Panel

Cardiovascular (CV)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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