Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) → OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph # OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph _Neurology · 21 CFR 882.1400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ ## Overview - **Product Code:** OLZ - **Device Name:** Automatic Event Detection Software For Polysomnograph With Electroencephalograph - **Regulation:** [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## Identification An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 36) Showing 20 most recent of 36 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253668](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K253668.md) | Onera SleepMap (SLEEPMAP) | Onera B.V. | Mar 8, 2026 | SESE | | [K250851](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K250851.md) | Hypnos (369054-200) | Cadwell Industries, Inc. | Dec 14, 2025 | SESE | | [K252330](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K252330.md) | DeepRESP | Nox Medical Ehf | Nov 17, 2025 | SESE | | [K250058](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K250058.md) | NEAT 001 | Brain Electrophysiology Laboratory Company, LLC | Apr 10, 2025 | SESE | | [K241960](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K241960.md) | DeepRESP | Nox Medical Ehf | Mar 14, 2025 | SESE | | [K242094](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K242094.md) | Dreem 3S | Beacon Biosignals, Inc. | Nov 22, 2024 | SESE | | [K233438](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K233438.md) | SleepStageML | Beacon Biosignals, Inc. | Mar 8, 2024 | SESE | | [K223539](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K223539.md) | Dreem 3S | Beacon Biosignals, Inc. | Aug 18, 2023 | SESE | | [K223922](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K223922.md) | SOMNUM (V.1.1.2.) | Honeynaps Co., Ltd. | Aug 16, 2023 | SESE | | [K221179](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K221179.md) | SomnoMetry | Neumetry Medical, Inc. | Sep 21, 2022 | SESE | | [K210034](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K210034.md) | EnsoSleep | Ensodata, Inc. | Jun 16, 2021 | SESE | | [K202142](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K202142.md) | Sleepware G3 | Respironics, Inc. | Oct 29, 2020 | SESE | | [K192469](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K192469.md) | Nox Sleep System | Nox Medical | Nov 13, 2019 | SESE | | [K182227](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K182227.md) | Esprit Nova | Neurozone Msh Incorporated | Jan 17, 2019 | SESE | | [K173366](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K173366.md) | NicoletOne | Natus Neurology Incorporated | Jul 20, 2018 | SESE | | [K163617](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K163617.md) | REMbrandt | Embla Systems | Apr 11, 2017 | SESE | | [K162627](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K162627.md) | EnsoSleep | Ensodata, Inc. | Mar 31, 2017 | SESE | | [K162140](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K162140.md) | RemLogic | Embla Systems | Dec 1, 2016 | SESE | | [K153353](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K153353.md) | SANDMAN ELITE | Embla Systems | Jun 23, 2016 | SESE | | [K153412](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ/K153412.md) | Sleep Profiler | Advanced Brain Monitoring, Inc. | Mar 14, 2016 | SESE | ## Top Applicants - Advanced Brain Monitoring, Inc. — 3 clearances - Beacon Biosignals, Inc. — 3 clearances - Embla Systems — 3 clearances - Respironics, Inc. — 3 clearances - Ensodata, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com