The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Lux-dx Insertable Cardiac Monitor, Mylux Software Mobile Application, Lux-dx Clinic Assistant Software, Application Server Device Services (ds) - Us.
| Device ID | K193473 |
| 510k Number | K193473 |
| Device Name: | LUX-Dx Insertable Cardiac Monitor, MyLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00802526613838 | K193473 | 000 |
| 00802526607615 | K193473 | 000 |
| 00802526607608 | K193473 | 000 |
| 00802526607370 | K193473 | 000 |
| 00802526607363 | K193473 | 000 |
| 00802526607103 | K193473 | 000 |