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

Polysmith Version 12.0

Name: Polysmith Version 12.0
Brand: Polysmith Version 12.0

Catalogue number 12.0, listed by Neurotronics, LLC, United States, under Automatic Event Detection Software For Polysomnograph With Electroencephalograph. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

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 Polysmith Version 12.0
Listed by	Neurotronics, LLC, 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
Record published	2020-04-01
Record revised	2025-04-10 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Polysmith Version 12.0
Catalogue number	Size	Status
12.0		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
DeepRESP	Nox Medical Ehf	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
K062943	2007-05-09

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.