FDA.report

510(k) K252330

Device
DeepRESP
Applicant
Nox Medical Ehf
510(k) number
K252330
Product code
OLZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-17
Date received
2025-07-25
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

Related Records

Applicant Contact

Contact
Elísabet Finnbogadóttir
Address
Katrinartuni 2, Is - 105 Reykjavik IS

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OLZ

510(k)DeviceApplicantDecision date
K253668Onera SleepMap (SLEEPMAP)Onera B.V.2026-03-08
K250851Hypnos (369054-200)Cadwell Industries, Inc.2025-12-14
K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC2025-04-10
K241960DeepRESPNox Medical Ehf2025-03-14
K242094Dreem 3SBeacon Biosignals, Inc.2024-11-22
K233438SleepStageMLBeacon Biosignals, Inc.2024-03-08
K223539Dreem 3SBeacon Biosignals, Inc.2023-08-18
K223922SOMNUM (V.1.1.2.)Honeynaps Co., Ltd.2023-08-16
K221179SomnoMetryNeumetry Medical, Inc.2022-09-21
K210034EnsoSleepEnsodata, Inc.2021-06-16
K202142Sleepware G3Respironics, Inc.2020-10-29
K192469Nox Sleep SystemNox Medical2019-11-13
K182227Esprit NovaNeurozone Msh Incorporated2019-01-17
K173366NicoletOneNatus Neurology Incorporated2018-07-20
K163617REMbrandtEmbla Systems2017-04-11