FDA 510(k) Applications for Medical Device Product Code "MXD"
(Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K170628 | BIOTRONIK, Inc | BioMonitor 2-AF, BioMonitor 2-S | 03/31/2017 |
| K132960 | BIOTRONIK, INC. | BIOMONITOR | 06/06/2014 |
| K143503 | BIOTRONIK, INC. | BioMonitor | 03/19/2015 |
| K152995 | BIOTRONIK, INC. | BioMonitor 2-AF, BioMonitor 2-S | 04/11/2016 |
| K171514 | BIOTRONIK, Inc. | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set | 06/29/2017 |
| K200444 | BIOTRONIK, Inc. | Biomonitor III, Biomonitor IIIm | 04/23/2020 |
| K201865 | Biotronik, Inc. | Biomonitor III, Biomonitor IIIm | 12/08/2020 |
| K190548 | Biotronik, Inc. | BIOMONITOR III, Remote Assistant III | 07/05/2019 |
| K221856 | BIOTRONIK, Inc. | BIOMONITOR IIIm, BIOMONITOR III | 07/27/2022 |
| K230375 | BIOTRONIK, Inc. | BIOMONITOR IV | 05/19/2023 |
| K231328 | Boston Scientific Corp | LUX-Dx II (M302); LUX-Dx II+ (M312) | 08/19/2023 |
| K210608 | Boston Scientific Corporation | LUX-Dx Insertable Cardiac Monitor | 05/25/2021 |
| K193473 | Boston Scientific Corporation | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US | 06/26/2020 |
| K150614 | MEDTRONIC INC. | Reveal LINQ | 08/06/2015 |
| K132649 | MEDTRONIC INC. | REVEAL LINQ INSERTABLE CARDIAC MONITOR | 02/14/2014 |
| K211304 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor | 05/28/2021 |
| K221962 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor | 08/25/2022 |
| K230553 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | 04/26/2023 |
| K200795 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | 07/03/2020 |
| K210484 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | 06/11/2021 |
| K160809 | MEDTRONIC, INC. | Reveal LINQ | 05/26/2016 |
| K160689 | MEDTRONIC, INC. | Reveal LINQ | 04/22/2016 |
| K162855 | Medtronic, Inc. | Reveal LINQ | 02/23/2017 |
| K223630 | Medtronic, Inc. | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | 04/05/2023 |
| K163460 | MEDTRONIC,INC. | Reveal LINQ Insertable Cardiac Monitor | 02/14/2017 |
| K212008 | Medtronic. Inc. | Reveal LINQ Insertable Cardiac Monitor | 07/22/2021 |
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