What is FDA product code OLZ?

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

Neurology › DiagnosticAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

DeepRESP

Name: DeepRESP
Brand: DeepRESP

DeepRESP is cloud-based software for analyzing sleep study recordings, with and without EEG signals. The FDA describes it as an aid in diagnosing various sleep disorders. The recordings may…

Registry build 21.09.26

DeepRESP is cloud-based software for analyzing sleep study recordings, with and without EEG signals. The FDA describes it as an aid in diagnosing various sleep disorders.

The recordings may be collected in a hospital, a patient’s home or an ambulatory setting. The indicated users are adults aged 22 and above in a clinical environment, by or on the order of a medical professional.

Analysis Outputs

The filing says DeepRESP marks sleep study signals to help identify events and annotate traces, calculates measures from recorded signals, and infers sleep staging with arousals, both with EEG and without EEG. Outputs require professional verification.

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OLZ
Manufacturer	City	Province	Registered as	Device types
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13

Record

Regulatory record for DeepRESP
Listed by	Nox Medical Ehf, IS
FDA product code	OLZ
Device type	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device class	Class 2
Regulation	21 CFR 882.1400
510(k)	K241960
Record published	2025-06-06

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only

Catalogue Numbers

Catalogue numbers for DeepRESP
Catalogue number	Size	Status
DEEPRESP		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sleepware	Respironics Inc.	8
Sleep Profiler	Advanced Brain Monitoring, Inc.	3
EnsoSleep	Ensodata, Inc.	3
Waveband	Beacon Biosignals, Inc.	2
Nox A1® EEG 5 Lead Gold Electrode Cable	Nox Medical Ehf	2
Nox A1® EEG Head Cable	Nox Medical Ehf	2
Nox C1 Kit	Nox Medical Ehf	2
Nox C1 Access Point	Nox Medical Ehf	2
Polysmith Version 12.0	Neurotronics, LLC	1
Nox A1s Recorder	Nox Medical Ehf	1
Sphinx HB710 Head Box	Neurotronics, LLC	1
Sleepware G3	Respironics Inc.	1

Showing 12 of 31. All products under Automatic Event Detection Software For Polysomnograph With Electroencephalograph

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252330	2025-11-17
K241960	2025-03-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.