OLZ
37 FDA 510(k) clearances · Product code
149 daysmedian time to decision
268 days90th percentile
37clearances measured
FDA profile
- Official device name
- Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Medical specialty
- Neurology
- FDA 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
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| Record | Firm | Date |
|---|---|---|
| SOMNUM (SOMNUM) (K253390) | Honeynaps Co., Ltd. | 2026-06-27 |
| Onera SleepMap (SLEEPMAP) (K253668) | Onera B.V. | 2026-03-08 |
| Hypnos (369054-200) (K250851) | Cadwell Industries, Inc. | 2025-12-14 |
| DeepRESP (K252330) | Nox Medical Ehf | 2025-11-17 |
| NEAT 001 (K250058) | Brain Electrophysiology Laboratory Company, LLC | 2025-04-10 |
| DeepRESP (K241960) | Nox Medical Ehf | 2025-03-14 |
| Dreem 3S (K242094) | Beacon Biosignals, Inc. | 2024-11-22 |
| SleepStageML (K233438) | Beacon Biosignals, Inc. | 2024-03-08 |
| Dreem 3S (K223539) | Beacon Biosignals, Inc. | 2023-08-18 |
| SOMNUM (V.1.1.2.) (K223922) | Honeynaps Co., Ltd. | 2023-08-16 |
| SomnoMetry (K221179) | Neumetry Medical, Inc. | 2022-09-21 |
| EnsoSleep (K210034) | Ensodata, Inc. | 2021-06-16 |
| Sleepware G3 (K202142) | Respironics, Inc. | 2020-10-29 |
| Nox Sleep System (K192469) | Nox Medical | 2019-11-13 |
| Esprit Nova (K182227) | Neurozone Msh Incorporated | 2019-01-17 |
| NicoletOne (K173366) | Natus Neurology Incorporated | 2018-07-20 |
| REMbrandt (K163617) | Embla Systems | 2017-04-11 |
| EnsoSleep (K162627) | Ensodata, Inc. | 2017-03-31 |
| RemLogic (K162140) | Embla Systems | 2016-12-01 |
| SANDMAN ELITE (K153353) | Embla Systems | 2016-06-23 |
| Sleep Profiler (K153412) | Advanced Brain Monitoring, Inc. | 2016-03-14 |
| Sleepware G3 (K142988) | Respironics, Inc. | 2015-03-16 |
| Zmachine (K142825) | Consolidated Research of Richmond, Inc. | 2015-01-20 |
| SLEEP PROFILER (K130007) | Advanced Brain Monitoring, Inc. | 2013-04-17 |
| SLEEP PROFILER (K120450) | Advanced Brain Monitoring, Inc. | 2012-09-19 |
| NATUS SLEEPWORKS, MODEL 104017 (K090277) | Excel-Tech Ltd. (Xltek) | 2011-04-19 |
| POLYSMITH SLEEP SYSTEM, MODEL NTI5498 (K062943) | Neurotronics, Inc. | 2007-05-09 |
| ALICE 5 (K040595) | Respironics, Inc. | 2004-03-18 |
| BIOSLEEP (K002622) | Oxford Biosignals Limited | 2000-10-23 |
| SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 (K963631) | Omega Results | 1997-04-02 |
| MEDILOG VISION (K961636) | Oxford Instruments, Plc. | 1997-01-17 |
| SENSORMEDICS 4000 SERIES SLEEP SYSTEM (K915856) | Sensor Medics Corp. | 1992-10-26 |
| SLEEPSCAN (K894155) | Biologic Systems Corp. | 1990-01-26 |
| MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM (K891383) | Oxford Medilog, Inc. | 1989-06-01 |
| SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) (K890513) | Micro Tronics Corp. | 1989-04-28 |
| MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS. (K871990) | Oxford Medilog, Inc. | 1987-10-07 |
| SLEEP ANALYZING COMPUTER (K862527) | Micro Tronics Corp. | 1986-10-06 |
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Every clearance here is in the API, with alerts when new ones post.