The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Lux-dx Insertable Cardiac Monitor.
| Device ID | K210608 |
| 510k Number | K210608 |
| Device Name: | LUX-Dx Insertable Cardiac Monitor |
| Classification | Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Applicant | Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 |
| Contact | Melissa Klamerus |
| Correspondent | Melissa Klamerus Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 |
| Product Code | MXD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-05-25 |
| Summary: | summary |