DeepRESP

FDA 510(k) K252330 · Nox Medical Ehf

Substantially Equivalent

510(k) numberK252330

Submission

Device name
DeepRESP
Applicant
Nox Medical Ehf
Reykjavik, IS
Received
July 25, 2025
Decision date
November 17, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OLZ – Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Specialty
Neurology

Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user

Other 510(k)s with product code OLZ

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K250851Hypnos (369054-200)OLZ · Traditional Cadwell Industries, Inc.12/14/2025SE
K250058Neat 001OLZ · Traditional Brain Electrophysiology Laboratory Company, LLC04/10/2025SE
K241960DeepRESPOLZ · Traditional Nox Medical Ehf03/14/2025SE
K242094Dreem 3SOLZ · Traditional Beacon Biosignals, Inc.11/22/2024SE
K233438SleepStageMLOLZ · Traditional Beacon Biosignals, Inc.03/08/2024SE
K223539Dreem 3SOLZ · Traditional Beacon Biosignals, Inc.08/18/2023SE
K223922Somnum (V.1.1.2.)OLZ · Traditional Honeynaps Co., Ltd.08/16/2023SE
K221179SomnoMetryOLZ · Traditional Neumetry Medical, Inc.09/21/2022SE

More from Neumetry Medical, Inc.

510(k)DeviceDecision
K260585Noxturnal WebOLV · Special 03/20/2026SE
K241960DeepRESPOLZ · Traditional 03/14/2025SE
K241288Noxturnal WebOLV · Traditional 12/23/2024SE
K151361Nox RIP Belts & CablesMNR · Traditional 11/06/2015SE

Questions and answers

When was DeepRESP cleared by the FDA?

DeepRESP (K252330) received a 510(k) decision of Substantially Equivalent on November 17, 2025, 115 days after the submission was received.

What is the product code of K252330?

The FDA product code is OLZ – Automatic Event Detection Software For Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.