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

Esprit Nova

Name: Esprit Nova
Brand: Esprit Nova

Esprit Nova is a software application that analyzes previously recorded physiological signals obtained during sleep.

Registry build 21.09.26

1manufacturer

1catalogue number

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 Esprit Nova
Listed by	Signalitica Inc
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)	K182227
Record published	2020-12-06
Record revised	2022-10-24 (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 Esprit Nova
Catalogue number	Size	Status
v 1.1		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
Polysmith Version 12.0	Neurotronics, LLC	1
Nox A1s Recorder	Nox Medical Ehf	1
Sphinx HB710 Head Box	Neurotronics, LLC	1

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

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.