Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System

Medtronic, Inc. · K223630 · 2023-04-05

Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System is an AI-enabled medical device from Medtronic, Inc., listed by FDA (510(k), K223630) with a decision date of 2023-04-05. Review panel: Cardiovascular.

FDA submission numberK223630
Pathway510(k)
CompanyMedtronic, Inc.
Review panel (specialty)Cardiovascular
FDA decision date2023-04-05
DecisionSubstantially Equivalent
Product codeMXD
ClassificationRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device class2
Regulation number870.1025
Review time (calendar days)121
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

More devices from Medtronic, Inc. · All Cardiovascular AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.