510(k) K231328
- Device
- LUX-Dx II (M302); LUX-Dx II+ (M312)
- Applicant
- Boston Scientific Corp
- 510(k) number
- K231328
- Product code
- MXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-19
- Date received
- 2023-05-08
- Regulation
- 870.1025
- Classification name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Melissa Klamerus
- Address
- 4100 Hamline Ave. N St Paul MN US 55112 55112
FDA Registration Numbers
- 3009380063
- 2124215
- 2182208
- 2017865
- 3018094310
- 3015544746
- 1028232
- 9616693
- 3004185781
- 9614453
- 9610139
- 3008973940
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | 2025-09-12 |
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| K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2021-07-22 |
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