Product Code: OLV FDA class 2 21 CFR 882.1400

Standard Polysomnograph With Electroencephalograph

Neurology

The Standard Polysomnograph With Electroencephalograph (product code OLV) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It is designed to acquire, display, store, and archive electroencephalographic signals from the brain along with other physiological signals such as electromyography, respiratory data, and oximetry for sleep recordings, and may support on-screen review and annotation by clinicians. The device is eligible for third-party review and is not an implant or life-sustaining device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OLV
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

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260585	Noxturnal Web	Mar 20, 2026	Substantially Equivalent	Nox Medical Ehf
K242447	Falcon HST	Feb 20, 2025	Substantially Equivalent	Compumedics Limited
K241288	Noxturnal Web	Dec 23, 2024	Substantially Equivalent	Nox Medical Ehf
K240700	HomeSleepTest (HST, HST REM+)	Dec 08, 2024	Substantially Equivalent	Somnomedics GmbH
K213007	Cerebra Sleep System	Jul 06, 2022	Substantially Equivalent	Cerebra Medical , Ltd.
K201054	SOMNOscreen plus	Aug 12, 2020	Substantially Equivalent	Somnomedics GmbH
K192624	ApneaTrak	Feb 20, 2020	Substantially Equivalent	Cadwell Industries, Inc.
K181709	Serenity Piezo Sensor, Serenity Thermocouple Sensor	Nov 16, 2018	Substantially Equivalent	Neurotronics, Inc.
K173868	Serenity Body Position Sensor, Serenity RIP Sensors	Jul 02, 2018	Substantially Equivalent	Neurotronics, Inc.
K173690	Grass TWin	Mar 09, 2018	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K172986	Zmachine Synergy	Dec 19, 2017	Substantially Equivalent	Consolidated Research of Richmond, Inc. Dba General Sleep CO
K172711	Comet-PLUS	Nov 03, 2017	Substantially Equivalent	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K161650	Polysmith Sleep System, Model NTI7593	Jan 19, 2017	Substantially Equivalent	Neurotronics, Inc.
K142774	Polysmith Sleep System	Feb 18, 2015	Substantially Equivalent	Neurotronics, Inc.
K131415	LIVE VIEW PANEL (LVP)	Aug 09, 2013	Substantially Equivalent	Neurotronics, Inc.
K111055	GALAXY SYSTEM; JUPITER	Dec 21, 2011	Substantially Equivalent	Personal Health Institute International
K101830	ZMACHINE, MODEL DT-100	Mar 31, 2011	Substantially Equivalent	Consolidated Research of Richmond, Inc.
K093728	BE MICRO, TREA	Apr 29, 2010	Substantially Equivalent	Eb Neuro S.P.A.
K073491	EEG-1100A SWITCH BOX	Jan 11, 2008	Substantially Equivalent	Nihon Kohden America, Inc.
K071782	MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES	Jan 10, 2008	Substantially Equivalent	Micromed S.P.A.
K050425	AURA-PSG	Oct 20, 2005	Substantially Equivalent	Astro-Med, Inc.
K052066	CEEGRAPH/SLEEPSCAN NETLINK TRAVELER	Aug 26, 2005	Substantially Equivalent	Bio-Logic Systems Corp.
K050833	ELECTRODE JUNCTION BOX, MODEL JE-921A	Apr 29, 2005	Substantially Equivalent	Nihon Kohden America, Inc.
K050143	OMNIPRO SYSTEM	Feb 01, 2005	Substantially Equivalent	Mays and Associates, Inc.
K042039	FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120	Nov 17, 2004	Substantially Equivalent	Cleveland Medical Devices, Inc.
K042364	PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES	Sep 30, 2004	Substantially Equivalent	Lamont Medical, Inc.
K033475	WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES	Jan 07, 2004	Substantially Equivalent	Nihon Kohden America, Inc.
K031202	MEDIPALM-20	May 01, 2003	Substantially Equivalent	Braebon Medical Corp.
K022249	NIGHTRON POLYSOMNOGRAPHY SYSTEM	Dec 31, 2002	Substantially Equivalent	Telediagnostic Systems, Inc.
K022037	XLTEK SLEEP SYSTEM	Sep 10, 2002	Substantially Equivalent	Excel Tech. , Ltd.
K021807	GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM	Aug 29, 2002	Substantially Equivalent	Grass Instrument Co.
K022121	PSG INPUT BOX, MODEL JE-912AK	Jul 29, 2002	Substantially Equivalent	Nihon Kohden America, Inc.
K021185	NERVUS MONITOR	Jul 12, 2002	Substantially Equivalent	Taugagreining HF
K012976	TWIN PLUS	Feb 12, 2002	Substantially Equivalent	Grass-Telefactor Divison
K013450	NOTTA AMBULATORY RECORDER	Jan 14, 2002	Substantially Equivalent	Stellate Systems
K012085	SOMNO STAR & SERIES SLEEP SYSTEM	Aug 02, 2001	Substantially Equivalent	Sensor Medics Corp.
K010728	HARMONE-SCHWARZER EEG SYSTEM	May 21, 2001	Substantially Equivalent	Stellate Systems
K010460	LIFELINES TRACKIT	May 14, 2001	Substantially Equivalent	Lifelines , Ltd.
K011204	NEUROFAX, MODELS EEG-1100A, EEG-9100A	May 08, 2001	Substantially Equivalent	Nihon Kohden America, Inc.
K003175	COMPUMEDICS SIESTA SYSTEM	Dec 27, 2000	Substantially Equivalent	Compumedics Limited
K003681	BIO-LOGIC SLEEPSCAN NETLINK	Dec 21, 2000	Substantially Equivalent	Bio-Logic Systems Corp.
K001013	MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY	May 16, 2000	Substantially Equivalent	Airsep Corp.
K000338	VITAPORT 3	Apr 26, 2000	Substantially Equivalent	Nihon Kohden America, Inc.
K994142	GRASS TS3201/6401 EEG AMPLIFIER SYSTEM	Mar 06, 2000	Substantially Equivalent	Grass Instrument Co.
K992742	NEUROFAX, MODEL EEG-1100A	Oct 14, 1999	Substantially Equivalent	Nihon Kohden America, Inc.
K992283	ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY	Aug 27, 1999	Substantially Equivalent	Airsep Corp.
K992291	H20- TETHERED OPTION	Aug 06, 1999	Substantially Equivalent	Grass-Telefactor Product Group
K991446	BIOSACA SYSTEM, MODEL 800	Jul 23, 1999	Substantially Equivalent	Biosys AB (Publ)
K991900	XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40	Jul 12, 1999	Substantially Equivalent	Excel Tech. , Ltd.
K990522	WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS	May 19, 1999	Substantially Equivalent	Lamont Medical, Inc.
K984580	BIOSACA SYSTEM	Mar 12, 1999	Substantially Equivalent	Biosys AB (Publ)
K983072	AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201	Dec 01, 1998	Substantially Equivalent	Nihon Kohden America, Inc.
K983913	MODIFICATION TO BIO-LOGIC SLEEPSCAN	Nov 25, 1998	Substantially Equivalent	Bio-Logic Systems Corp.
K974583	DEEGLITE	Jun 09, 1998	Substantially Equivalent	Grass-Telefactor Product Group
K974587	H2O	Mar 09, 1998	Substantially Equivalent	Grass-Telefactor Product Group
K971813	EMBLA	Jan 16, 1998	Substantially Equivalent	Ferguson Medical
K971867	ALICE 4R SYSTEM	Aug 13, 1997	Substantially Equivalent	Healthdyne Technologies, Inc.
K970951	GRASS BRAINWAVE SOFTWARE	May 19, 1997	Substantially Equivalent	Astro-Med, Inc.
K961638	MEDILOG MPA-S	Jan 17, 1997	Substantially Equivalent	Oxford Instruments Medical Systems
K922106	ALICE	Jul 06, 1994	Substantially Equivalent	Healthdyne, Inc.
K934599	SANDMAN	Jan 27, 1994	Substantially Equivalent	Melville Software , Ltd.
K860458	ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.	Aug 12, 1986	Substantially Equivalent	Oxford Medilog, Inc.
K854665	4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH	Jun 05, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K860219	SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM	Apr 17, 1986	Substantially Equivalent	Grass-Telefactor Product Group