Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Regulation 882.1400
5510(k)s in 12 months (38 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Brain Monitoring, Inc. | 3 | 0 |
| Beacon Biosignals, Inc. | 3 | 0 |
| Embla Systems | 3 | 0 |
| Respironics, Inc. | 3 | 0 |
| Ensodata, Inc. | 2 | 0 |
| Honeynaps Co., Ltd. | 2 | 0 |
| Micro Tronics Corp. | 2 | 0 |
| Neurotronics, Inc. | 2 | 0 |
| Nox Medical Ehf | 2 | 0 |
| Oxford Medilog, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K261521 | Sleep Analysis Module Neurotronics, LLC | OLZ |
| Jun 27, 2026 | K253390 | SOMNUM (SOMNUM) Honeynaps Co., Ltd., KR | OLZ |
| Mar 8, 2026 | K253668 | Onera SleepMap (SLEEPMAP) Onera B.V., NL | OLZ |
| Dec 14, 2025 | K250851 | Hypnos (369054-200) Cadwell Industries, Inc. | OLZ |
| Nov 17, 2025 | K252330 | DeepRESP Nox Medical Ehf, IS | OLZ |
| Apr 10, 2025 | K250058 | NEAT 001 Brain Electrophysiology Laboratory Company, LLC | OLZ |
| Mar 14, 2025 | K241960 | DeepRESP Nox Medical Ehf, IS | OLZ |
| Nov 22, 2024 | K242094 | Dreem 3S Beacon Biosignals, Inc. | OLZ |
| Mar 8, 2024 | K233438 | SleepStageML Beacon Biosignals, Inc. | OLZ |
| Aug 18, 2023 | K223539 | Dreem 3S Beacon Biosignals, Inc. | OLZ |
| Aug 16, 2023 | K223922 | SOMNUM (V.1.1.2.) Honeynaps Co., Ltd., KR | OLZ |
| Sep 21, 2022 | K221179 | SomnoMetry Neumetry Medical, Inc. | OLZ |
| Jun 16, 2021 | K210034 | EnsoSleep Ensodata, Inc. | OLZ |
| Oct 29, 2020 | K202142 | Sleepware G3 Respironics, Inc. | OLZ |
| Nov 13, 2019 | K192469 | Nox Sleep System Nox Medical, IS | OLZ |
| Jan 17, 2019 | K182227 | Esprit Nova Neurozone Msh Incorporated, CA | OLZ |
| Jul 20, 2018 | K173366 | NicoletOne Natus Neurology Incorporated | OLZ |
| Apr 11, 2017 | K163617 | REMbrandt Embla Systems, CA | OLZ |
| Mar 31, 2017 | K162627 | EnsoSleep Ensodata, Inc. | OLZ |
| Dec 1, 2016 | K162140 | RemLogic Embla Systems, CA | OLZ |
| Jun 23, 2016 | K153353 | SANDMAN ELITE Embla Systems, CA | OLZ |
| Mar 14, 2016 | K153412 | Sleep Profiler Advanced Brain Monitoring, Inc. | OLZ |
| Mar 16, 2015 | K142988 | Sleepware G3 Respironics, Inc. | OLZ |
| Jan 20, 2015 | K142825 | Zmachine Consolidated Research of Richmond, Inc. | OLZ |
| Apr 17, 2013 | K130007 | SLEEP PROFILER Advanced Brain Monitoring, Inc. | OLZ |
| Sep 19, 2012 | K120450 | SLEEP PROFILER Advanced Brain Monitoring, Inc. | OLZ |
| Apr 19, 2011 | K090277 | NATUS SLEEPWORKS, MODEL 104017 Excel-Tech Ltd. (Xltek), CA | OLZ |
| May 9, 2007 | K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 Neurotronics, Inc. | OLZ |
| Mar 18, 2004 | K040595 | ALICE 5 Respironics, Inc. | OLZ |
| Oct 23, 2000 | K002622 | BIOSLEEP Oxford Biosignals Limited, GB | OLZ |
| Apr 2, 1997 | K963631 | SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 Omega Results | OLZ |
| Jan 17, 1997 | K961636 | MEDILOG VISION Oxford Instruments, Plc. | OLZ |
| Oct 26, 1992 | K915856 | SENSORMEDICS 4000 SERIES SLEEP SYSTEM Sensor Medics Corp. | OLZ |
| Jan 26, 1990 | K894155 | SLEEPSCAN Biologic Systems Corp. | OLZ |
| Jun 1, 1989 | K891383 | MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM Oxford Medilog, Inc. | OLZ |
| Apr 28, 1989 | K890513 | SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) Micro Tronics Corp. | OLZ |
| Oct 7, 1987 | K871990 | MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS. Oxford Medilog, Inc. | OLZ |
| Oct 6, 1986 | K862527 | SLEEP ANALYZING COMPUTER Micro Tronics Corp. | OLZ |
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