OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph Class II
FDA product code OLZ covers "Automatic Event Detection Software For Polysomnograph With Electroencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253390 | honeynaps co | SOMNUM (SOMNUM) | June 27, 2026 |
| 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 |