The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- CanadaENSOSLEEP106528
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-06 | 1 | — |
| 2025-01 | 0 | 1 |
| 2025-08 | 0 | 1.5 |
No recalls linked.
- 510(k)K210034Substantially equivalent (SESE) · 2021-06-16clearance family
Predicate lineage
- K210034
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
- Alice 6 Respironics, Inc.
- Cerebra Sleep System Cerebra Medical Ltd
- DeepRESP Nox Medical ehf.
- Embla Embla Systems Ltd
- Esprit Nova Signalitica Inc
- Live View Panel Pro Version 2.0 Neurotronics, LLC
- Live View Panel Version 1.3 Neurotronics, LLC
- Live View Panel Version 1.4 Neurotronics, LLC
- NEAT Brain Electrophysiology Laboratory Company, LLC
- Nox A1 Carry Case Nox Medical ehf.
- Nox A1 EEG 5 Lead Gold Electrode Cable Nox Medical ehf.
- Nox A1 EEG Head Cable Nox Medical ehf.