LEL
- Product code
- LEL
- Device name
- Device, Sleep Assessment
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5050
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 19
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252981 | 2025-12-22 | Empatica S.r.l. | EmbraceMini | |
| K251574 | 2025-07-31 | Ambulatory Monitoring, Inc. | Sleep Watch | |
| K243513 | 2025-04-16 | Pneumowave, Ltd. | DCM (PW-DCM) | |
| K233987 | 2024-06-17 | Arbor Medical Innovations, LLC | VERABAND | |
| K233618 | 2024-04-03 | Oxehealth Limited | Oxevision Sleep Device |
Official FDA classification page: LEL
Classification and pathway per current FDA publications. Data from openFDA (CC0).