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

EnsoSleep

Name: EnsoSleep
Brand: EnsoSleep

EnsoSleep is software that analyzes previously recorded physiological signals from sleep studies. It applies automated algorithms to raw and derived signals to identify respiratory events,…

Registry build 21.09.26

EnsoSleep is software that analyzes previously recorded physiological signals from sleep studies. It applies automated algorithms to raw and derived signals to identify respiratory events, sleep stages, arousals, leg movements and other events for review.

The filing describes use with adult and pediatric patients aged 13 or older, including at-home and in-lab studies. Results and signals are displayed for clinician verification and editing. The software marks events of interest but does not interpret results or suggest a diagnosis.

Listed Item

Automated sleep study scoring and report generation by EnsoData

Clinician Review

EnsoSleep operates under clinician supervision. Qualified clinicians verify automatically scored events and may manually mark or edit them before the results enter a sleep-study report; physicians remain responsible for diagnosis.

1manufacturer

3catalogue numbers in this listing

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 EnsoSleep
Listed by	Ensodata, 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)	K210034
Record published	2024-02-23
Record revised	2026-03-09 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date
Distribution end date	2025-04-14

Catalogue Numbers

Catalogue numbers for EnsoSleep
Catalogue number	Size	Status
8		In distribution
7.0		Withdrawn
01.1		Withdrawn

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
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
K210034	2021-06-16
K162627	2017-03-31

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.