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

Sleep Profiler

Name: Sleep Profiler
Brand: Sleep Profiler

Sleep Profiler software analyzes previously recorded physiological signals to help clinicians assess adult sleep quality. It reads EDF files meeting defined specifications and applies…

Registry build 21.09.26

Sleep Profiler software analyzes previously recorded physiological signals to help clinicians assess adult sleep quality. It reads EDF files meeting defined specifications and applies algorithms to identify sleep stages, arousals and snoring.

The analysis derives information from signals such as EEG, pulse and movement. Clinicians can inspect and edit the derived signals and automated results before they enter a sleep-study report.

Listed Item

Sleep Profiler Desktop Software

Review and Report Features

The software flags and rejects poor-quality EEG periods and can display optional ECG, EOG, EMG or EEG traces for visual review. Questionnaire and medical-history information can be combined with the signal analysis. Its obstructive-sleep-apnea output is a pretest probability for referral, rather than a diagnosis.

1manufacturer

3catalogue numbers in this listing

3510(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 Sleep Profiler
Listed by	Advanced Brain Monitoring, Inc., United States
FDA product code	OLZ
Device type	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device class	Class 2
Regulation	21 CFR 882.1400
Establishment	Manufacturer
510(k)	K120450
Record published	2023-10-23
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Sleep Profiler
Catalogue number	Size	Status
SP42-5402		In distribution
Sleep Profiler Desktop Software		In distribution
Sleep Profiler Portal Software		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sleepware	Respironics Inc.	8
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
DeepRESP	Nox Medical Ehf	1
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
K153412	2016-03-14
K130007	2013-04-17
K120450	2012-09-19

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.