OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph Class II
Classification Details
- Product Code
- OLZ
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253668 | onera | Onera SleepMap (SLEEPMAP) | March 8, 2026 |
| K250851 | cadwell industries | Hypnos (369054-200) | December 14, 2025 |
| K252330 | nox medical ehf | DeepRESP | November 17, 2025 |
| K250058 | brain electrophysiology laboratory company | NEAT 001 | April 10, 2025 |
| K241960 | nox medical ehf | DeepRESP | March 14, 2025 |
| K242094 | beacon biosignals | Dreem 3S | November 22, 2024 |
| K233438 | beacon biosignals | SleepStageML | March 8, 2024 |
| K223539 | beacon biosignals | Dreem 3S | August 18, 2023 |
| K223922 | honeynaps co | SOMNUM (V.1.1.2.) | August 16, 2023 |
| K221179 | neumetry medical | SomnoMetry | September 21, 2022 |
| K210034 | ensodata | EnsoSleep | June 16, 2021 |
| K202142 | respironics | Sleepware G3 | October 29, 2020 |
| K192469 | nox medical | Nox Sleep System | November 13, 2019 |
| K182227 | neurozone msh incorporated | Esprit Nova | January 17, 2019 |
| K173366 | natus neurology incorporated | NicoletOne | July 20, 2018 |
| K163617 | embla systems | REMbrandt | April 11, 2017 |
| K162627 | ensodata | EnsoSleep | March 31, 2017 |
| K162140 | embla systems | RemLogic | December 1, 2016 |
| K153353 | embla systems | SANDMAN ELITE | June 23, 2016 |
| K153412 | advanced brain monitoring | Sleep Profiler | March 14, 2016 |