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

Sleepware · Automatic Event Detection Software for Polysomnograph with Electroencephalograph → Neurology

Name: Sleepware
Brand: Sleepware

1manufacturer

8catalogue 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 Sleepware
Listed by	Respironics 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	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2017-10-10
Record revised	2021-03-05 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2021-03-05

Catalogue Numbers

Catalogue numbers for Sleepware
Catalogue number	Size	Status
Sleepware G3 Software, Multi-Lingual – 3		In distribution
3.8		In distribution
3.8		In distribution
Sleepware G3 Software, English – 3		In distribution
3.8		In distribution
3.8		In distribution
Sleepware G3 Software, Web download – 3		In distribution
Sleepware G3 Software, (Japan Only) – 3		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
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
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
K202142	2020-10-29
K142988	2015-03-16
K040595	2004-03-18

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.

Sleepware