OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OLZ |
|---|---|
| Device Name | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
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 | Onera SleepMap (SLEEPMAP) | Onera B.V. | Mar 8, 2026 | SESE |
| K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | Dec 14, 2025 | SESE |
| K252330 | DeepRESP | Nox Medical Ehf | Nov 17, 2025 | SESE |
| K250058 | NEAT 001 | Brain Electrophysiology Laboratory Company, LLC | Apr 10, 2025 | SESE |
| K241960 | DeepRESP | Nox Medical Ehf | Mar 14, 2025 | SESE |
| K242094 | Dreem 3S | Beacon Biosignals, Inc. | Nov 22, 2024 | SESE |
| K233438 | SleepStageML | Beacon Biosignals, Inc. | Mar 8, 2024 | SESE |
| K223539 | Dreem 3S | Beacon Biosignals, Inc. | Aug 18, 2023 | SESE |
| K223922 | SOMNUM (V.1.1.2.) | Honeynaps Co., Ltd. | Aug 16, 2023 | SESE |
| K221179 | SomnoMetry | Neumetry Medical, Inc. | Sep 21, 2022 | SESE |
| K210034 | EnsoSleep | Ensodata, Inc. | Jun 16, 2021 | SESE |
| K202142 | Sleepware G3 | Respironics, Inc. | Oct 29, 2020 | SESE |
| K192469 | Nox Sleep System | Nox Medical | Nov 13, 2019 | SESE |
| K182227 | Esprit Nova | Neurozone Msh Incorporated | Jan 17, 2019 | SESE |
| K173366 | NicoletOne | Natus Neurology Incorporated | Jul 20, 2018 | SESE |
| K163617 | REMbrandt | Embla Systems | Apr 11, 2017 | SESE |
| K162627 | EnsoSleep | Ensodata, Inc. | Mar 31, 2017 | SESE |
| K162140 | RemLogic | Embla Systems | Dec 1, 2016 | SESE |
| K153353 | SANDMAN ELITE | Embla Systems | Jun 23, 2016 | SESE |
| K153412 | 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
