LUX-Dx II (M302); LUX-Dx II+ (M312)
FDA 510(k) clearance K231328 · decided 2023-08-19
Clearance details
- K-number
- K231328
- Device name
- LUX-Dx II (M302); LUX-Dx II+ (M312)
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2023-05-08
- Decision date
- 2023-08-19
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- MXD
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Mo recall (Z-2048-2026) | Boston Scientific Corporation | 2026-05-01 |
| LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON E recall (Z-2049-2026) | Boston Scientific Corporation | 2026-05-01 |
| Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, recall (Z-0226-2025) | Boston Scientific Corporation | 2024-10-25 |