9 devices · 7 companies · 2021 to 2026
Product code OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph
9 devices under product code OLZ, 2021 to 2026, from 7 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (9 of 9 here), the regulation, and MAUDE report counts by product code.
Automatic Event Detection Software For Polysomnograph With Electroencephalograph. 21 CFR 882.1400, Class II. Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user MAUDE held 10 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| SOMNUMK253390 · 510(k) | Honeynaps Co., Ltd. | Neurology | database entry | |
| Onera SleepMapK253668 · 510(k) | Onera B.V. | Neurology | database entry | |
| DeepRESPK252330 · 510(k) | Nox Medical Ehf | Neurology | database entry | |
| DeepRESPK241960 · 510(k) | Nox Medical ehf | Neurology | database entry | |
| Dreem 3SK242094 · 510(k) | Beacon Biosignals, Inc. | Neurology | database entry | |
| SleepStageMLK233438 · 510(k) | Beacon Biosignals, Inc. | Neurology | database entry | |
| Dreem 3SK223539 · 510(k) | Beacon Biosignals, Inc. | Neurology | database entry | |
| SomnoMetryK221179 · 510(k) | Neumetry Medical Inc | Neurology | database entry | |
| EnsoSleepK210034 · 510(k) | EnsoData, Inc. | Neurology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.