Product Code: OLZ FDA class 2 21 CFR 882.1400

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Neurology

The Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It automatically marks EEG and polysomnograph signals to aid identification of sleep-related events, calculates simple measures from recorded signals, and all output is subject to verification by a qualified user. The device is not eligible for third-party review and is not an implant or life-sustaining device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code OLZ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: OLZ
Device Class: FDA class 2
Regulation Number: 882.1400
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253668	Onera SleepMap (SLEEPMAP)	Mar 08, 2026	Substantially Equivalent	Onera B.V.
K250851	Hypnos (369054-200)	Dec 14, 2025	Substantially Equivalent	Cadwell Industries, Inc.
K252330	DeepRESP	Nov 17, 2025	Substantially Equivalent	Nox Medical Ehf
K250058	NEAT 001	Apr 10, 2025	Substantially Equivalent	Brain Electrophysiology Laboratory Company, LLC
K241960	DeepRESP	Mar 14, 2025	Substantially Equivalent	Nox Medical Ehf
K242094	Dreem 3S	Nov 22, 2024	Substantially Equivalent	Beacon Biosignals, Inc.
K233438	SleepStageML	Mar 08, 2024	Substantially Equivalent	Beacon Biosignals, Inc.
K223539	Dreem 3S	Aug 18, 2023	Substantially Equivalent	Beacon Biosignals, Inc.
K223922	SOMNUM (V.1.1.2.)	Aug 16, 2023	Substantially Equivalent	Honeynaps Co., Ltd.
K221179	SomnoMetry	Sep 21, 2022	Substantially Equivalent	Neumetry Medical, Inc.
K210034	EnsoSleep	Jun 16, 2021	Substantially Equivalent	Ensodata, Inc.
K202142	Sleepware G3	Oct 29, 2020	Substantially Equivalent	Respironics, Inc.
K192469	Nox Sleep System	Nov 13, 2019	Substantially Equivalent	Nox Medical
K182227	Esprit Nova	Jan 17, 2019	Substantially Equivalent	Neurozone Msh Incorporated
K173366	NicoletOne	Jul 20, 2018	Substantially Equivalent	Natus Neurology Incorporated
K163617	REMbrandt	Apr 11, 2017	Substantially Equivalent	Embla Systems
K162627	EnsoSleep	Mar 31, 2017	Substantially Equivalent	Ensodata, Inc.
K162140	RemLogic	Dec 01, 2016	Substantially Equivalent	Embla Systems
K153353	SANDMAN ELITE	Jun 23, 2016	Substantially Equivalent	Embla Systems
K153412	Sleep Profiler	Mar 14, 2016	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K142988	Sleepware G3	Mar 16, 2015	Substantially Equivalent	Respironics, Inc.
K142825	Zmachine	Jan 20, 2015	Substantially Equivalent	Consolidated Research of Richmond, Inc.
K130007	SLEEP PROFILER	Apr 17, 2013	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K120450	SLEEP PROFILER	Sep 19, 2012	Substantially Equivalent	Advanced Brain Monitoring, Inc.
K090277	NATUS SLEEPWORKS, MODEL 104017	Apr 19, 2011	Substantially Equivalent	Excel-Tech Ltd. (Xltek)
K062943	POLYSMITH SLEEP SYSTEM, MODEL NTI5498	May 09, 2007	Substantially Equivalent	Neurotronics, Inc.
K040595	ALICE 5	Mar 18, 2004	Substantially Equivalent	Respironics, Inc.
K002622	BIOSLEEP	Oct 23, 2000	Substantially Equivalent	Oxford Biosignals Limited
K963631	SLEEP STUDY ANALYSIS (SSA) VERSION 96.10	Apr 02, 1997	Substantially Equivalent	Omega Results
K961636	MEDILOG VISION	Jan 17, 1997	Substantially Equivalent	Oxford Instruments, Plc.
K915856	SENSORMEDICS 4000 SERIES SLEEP SYSTEM	Oct 26, 1992	Substantially Equivalent	Sensor Medics Corp.
K894155	SLEEPSCAN	Jan 26, 1990	Substantially Equivalent	Biologic Systems Corp.
K891383	MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM	Jun 01, 1989	Substantially Equivalent	Oxford Medilog, Inc.
K890513	SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)	Apr 28, 1989	Substantially Equivalent	Micro Tronics Corp.
K871990	MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.	Oct 07, 1987	Substantially Equivalent	Oxford Medilog, Inc.
K862527	SLEEP ANALYZING COMPUTER	Oct 06, 1986	Substantially Equivalent	Micro Tronics Corp.