510(k) K192469
- Device
- Nox Sleep System
- Applicant
- Nox Medical
- 510(k) number
- K192469
- Product code
- OLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-11-13
- Date received
- 2019-09-09
- Regulation
- 882.1400
- Classification name
- Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kolburn E Ottosdottir
- Address
- Katrinartuni 2 Reykjavik IS 105 105
FDA Registration Numbers#
- 3011120183
- 9612330
- 3007616088
- 3010399798
- 9613619
- 3018783526
- 3033526676
- 3013724298
- 3000126629
- 2518422
- 3002797442
- 3004964738
- 1063925
- 3012428212
- 3010611950
- 3027726372
- 1650946
- 3033708293
- 3009770872
- 3023272766
- 3007389703
- 3038562397
- 3008253300
- 3007611554
- 3026753386
Source Documents#
Other 510(k) Records For Product Code OLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253668 | Onera SleepMap (SLEEPMAP) | Onera B.V. | 2026-03-08 |
| K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | 2025-12-14 |
| K252330 | DeepRESP | Nox Medical Ehf | 2025-11-17 |
| K250058 | NEAT 001 | Brain Electrophysiology Laboratory Company, LLC | 2025-04-10 |
| K241960 | DeepRESP | Nox Medical Ehf | 2025-03-14 |
| K242094 | Dreem 3S | Beacon Biosignals, Inc. | 2024-11-22 |
| K233438 | SleepStageML | Beacon Biosignals, Inc. | 2024-03-08 |
| K223539 | Dreem 3S | Beacon Biosignals, Inc. | 2023-08-18 |
| K223922 | SOMNUM (V.1.1.2.) | Honeynaps Co., Ltd. | 2023-08-16 |
| K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022-09-21 |
| K210034 | EnsoSleep | Ensodata, Inc. | 2021-06-16 |
| K202142 | Sleepware G3 | Respironics, Inc. | 2020-10-29 |
| K182227 | Esprit Nova | Neurozone Msh Incorporated | 2019-01-17 |
| K173366 | NicoletOne | Natus Neurology Incorporated | 2018-07-20 |
| K163617 | REMbrandt | Embla Systems | 2017-04-11 |
Legacy Summary#
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FDA Review#
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