FDA Product Code
FDA Product Code OLZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253390 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | 2026-06-27 | Traditional | PDF ↗ |
| K253668 | Onera SleepMap (SLEEPMAP) | Onera B.V. | 2026-03-08 | Traditional | PDF ↗ |
| K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | 2025-12-14 | Traditional | PDF ↗ |
| K252330 | DeepRESP | Nox Medical Ehf | 2025-11-17 | Traditional | PDF ↗ |
| K250058 | NEAT 001 | Brain Electrophysiology Laboratory Company, LLC | 2025-04-10 | Traditional | PDF ↗ |
| K241960 | DeepRESP | Nox Medical Ehf | 2025-03-14 | Traditional | PDF ↗ |
| K242094 | Dreem 3S | Beacon Biosignals, Inc. | 2024-11-22 | Traditional | PDF ↗ |
| K233438 | SleepStageML | Beacon Biosignals, Inc. | 2024-03-08 | Traditional | PDF ↗ |
| K223539 | Dreem 3S | Beacon Biosignals, Inc. | 2023-08-18 | Traditional | PDF ↗ |
| K223922 | SOMNUM (V.1.1.2.) | Honeynaps Co., Ltd. | 2023-08-16 | Traditional | PDF ↗ |
| K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022-09-21 | Traditional | PDF ↗ |
| K210034 | EnsoSleep | Ensodata, Inc. | 2021-06-16 | Traditional | PDF ↗ |
| K202142 | Sleepware G3 | Respironics, Inc. | 2020-10-29 | Traditional | PDF ↗ |
| K192469 | Nox Sleep System | Nox Medical | 2019-11-13 | Traditional | PDF ↗ |
| K182227 | Esprit Nova | Neurozone Msh Incorporated | 2019-01-17 | Traditional | PDF ↗ |
| K173366 | NicoletOne | Natus Neurology Incorporated | 2018-07-20 | Traditional | PDF ↗ |
| K163617 | REMbrandt | Embla Systems | 2017-04-11 | Traditional | PDF ↗ |
| K162627 | EnsoSleep | Ensodata, Inc. | 2017-03-31 | Traditional | PDF ↗ |
| K162140 | RemLogic | Embla Systems | 2016-12-01 | Traditional | PDF ↗ |
| K153353 | SANDMAN ELITE | Embla Systems | 2016-06-23 | Traditional | PDF ↗ |
| K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016-03-14 | Traditional | PDF ↗ |
| K142988 | Sleepware G3 | Respironics, Inc. | 2015-03-16 | Traditional | PDF ↗ |
| K142825 | Zmachine | Consolidated Research of Richmond, Inc. | 2015-01-20 | Traditional | PDF ↗ |
| K130007 | SLEEP PROFILER | Advanced Brain Monitoring, Inc. | 2013-04-17 | Traditional | PDF ↗ |
| K120450 | SLEEP PROFILER | Advanced Brain Monitoring, Inc. | 2012-09-19 | Traditional | PDF ↗ |
| K090277 | NATUS SLEEPWORKS, MODEL 104017 | Excel-Tech Ltd. (Xltek) | 2011-04-19 | Traditional | PDF ↗ |
| K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 | Neurotronics, Inc. | 2007-05-09 | Traditional | PDF ↗ |
| K040595 | ALICE 5 | Respironics, Inc. | 2004-03-18 | Abbreviated | PDF ↗ |
| K002622 | BIOSLEEP | Oxford Biosignals Limited | 2000-10-23 | Traditional | PDF ↗ |
| K963631 | SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 | Omega Results | 1997-04-02 | Traditional | PDF ↗ |
| K961636 | MEDILOG VISION | Oxford Instruments, Plc. | 1997-01-17 | Traditional | PDF ↗ |
| K915856 | SENSORMEDICS 4000 SERIES SLEEP SYSTEM | Sensor Medics Corp. | 1992-10-26 | Traditional | PDF ↗ |
| K894155 | SLEEPSCAN | Biologic Systems Corp. | 1990-01-26 | Traditional | PDF ↗ |
| K891383 | MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM | Oxford Medilog, Inc. | 1989-06-01 | Traditional | PDF ↗ |
| K890513 | SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) | Micro Tronics Corp. | 1989-04-28 | Traditional | PDF ↗ |
| K871990 | MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS. | Oxford Medilog, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K862527 | SLEEP ANALYZING COMPUTER | Micro Tronics Corp. | 1986-10-06 | Traditional | PDF ↗ |
Product code OLZ · Class II · Neurology. Data: openFDA.