FDA 510(k) Applications for Medical Device Product Code "OLZ"
(Automatic Event Detection Software For Polysomnograph With Electroencephalograph)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K153412 | ADVANCED BRAIN MONITORING, INC. | Sleep Profiler | 03/14/2016 |
| K120450 | ADVANCED BRAIN MONITORING, INC. | SLEEP PROFILER | 09/19/2012 |
| K130007 | ADVANCED BRAIN MONITORING, INC. | SLEEP PROFILER | 04/17/2013 |
| K223539 | Beacon Biosignals, Inc. | Dreem 3S | 08/18/2023 |
| K142825 | CONSOLIDATED RESEARCH OF RICHMOND, INC | Zmachine | 01/20/2015 |
| K163617 | Embla Systems | REMbrandt | 04/11/2017 |
| K162140 | EMBLA SYSTEMS | RemLogic | 12/01/2016 |
| K153353 | EMBLA SYSTEMS | SANDMAN ELITE | 06/23/2016 |
| K162627 | EnsoData, Inc. | EnsoSleep | 03/31/2017 |
| K210034 | EnsoData, Inc. | EnsoSleep | 06/16/2021 |
| K090277 | EXCEL-TECH LTD. (XLTEK) | NATUS SLEEPWORKS, MODEL 104017 | 04/19/2011 |
| K223922 | Honeynaps Co., Ltd | SOMNUM (V.1.1.2.) | 08/16/2023 |
| K173366 | Natus Neurology Incorporated | NicoletOne | 07/20/2018 |
| K221179 | Neumetry Medical Inc | SomnoMetry | 09/21/2022 |
| K062943 | NEUROTRONICS, INC. | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 | 05/09/2007 |
| K182227 | Neurozone MSH Incorporated | Esprit Nova | 01/17/2019 |
| K192469 | Nox Medical | Nox Sleep System | 11/13/2019 |
| K963631 | OMEGA RESULTS | SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 | 04/02/1997 |
| K002622 | OXFORD BIOSIGNALS LIMITED | BIOSLEEP | 10/23/2000 |
| K961636 | OXFORD INSTRUMENTS, PLC. | MEDILOG VISION | 01/17/1997 |
| K040595 | RESPIRONICS, INC. | ALICE 5 | 03/18/2004 |
| K142988 | RESPIRONICS, INC. | Sleepware G3 | 03/16/2015 |
| K202142 | Respironics, Inc. | Sleepware G3 | 10/29/2020 |
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