K231328 is an FDA 510(k) clearance for the LUX-Dx II (M302). This device is classified as a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II - Special Controls, product code MXD).
Submitted by Boston Scientific Corp (St Paul, US). The FDA issued a Cleared decision on August 19, 2023, 103 days after receiving the submission on May 8, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K231328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2023 |
| Decision Date | August 19, 2023 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |