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OLV

64 FDA 510(k) clearances · Product code

88 daysmedian time to decision
245 days90th percentile
64clearances measured

FDA profile

Official device name
Standard Polysomnograph With Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Medical specialty
Neurology
Flags
Third-party review eligible
FDA 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.
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RecordFirmDate
Noxturnal Web (K260585)Nox Medical Ehf2026-03-20
Falcon HST (K242447)Compumedics Limited2025-02-20
Noxturnal Web (K241288)Nox Medical Ehf2024-12-23
HomeSleepTest (HST, HST REM+) (K240700)Somnomedics GmbH2024-12-08
Cerebra Sleep System (K213007)Cerebra Medical , Ltd.2022-07-06
SOMNOscreen plus (K201054)Somnomedics GmbH2020-08-12
ApneaTrak (K192624)Cadwell Industries, Inc.2020-02-20
Serenity Piezo Sensor, Serenity Thermocouple Sensor (K181709)Neurotronics, Inc.2018-11-16
Serenity Body Position Sensor, Serenity RIP Sensors (K173868)Neurotronics, Inc.2018-07-02
Grass TWin (K173690)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-03-09
Zmachine Synergy (K172986)Consolidated Research of Richmond, Inc. Dba General Sleep CO2017-12-19
Comet-PLUS (K172711)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2017-11-03
Polysmith Sleep System, Model NTI7593 (K161650)Neurotronics, Inc.2017-01-19
Polysmith Sleep System (K142774)Neurotronics, Inc.2015-02-18
LIVE VIEW PANEL (LVP) (K131415)Neurotronics, Inc.2013-08-09
GALAXY SYSTEM; JUPITER (K111055)Personal Health Institute International2011-12-21
ZMACHINE, MODEL DT-100 (K101830)Consolidated Research of Richmond, Inc.2011-03-31
BE MICRO, TREA (K093728)Eb Neuro S.P.A.2010-04-29
EEG-1100A SWITCH BOX (K073491)Nihon Kohden America, Inc.2008-01-11
MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES (K071782)Micromed S.P.A.2008-01-10
AURA-PSG (K050425)Astro-Med, Inc.2005-10-20
CEEGRAPH/SLEEPSCAN NETLINK TRAVELER (K052066)Bio-Logic Systems Corp.2005-08-26
ELECTRODE JUNCTION BOX, MODEL JE-921A (K050833)Nihon Kohden America, Inc.2005-04-29
OMNIPRO SYSTEM (K050143)Mays and Associates, Inc.2005-02-01
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 (K042039)Cleveland Medical Devices, Inc.2004-11-17
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES (K042364)Lamont Medical, Inc.2004-09-30
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES (K033475)Nihon Kohden America, Inc.2004-01-07
MEDIPALM-20 (K031202)Braebon Medical Corp.2003-05-01
NIGHTRON POLYSOMNOGRAPHY SYSTEM (K022249)Telediagnostic Systems, Inc.2002-12-31
XLTEK SLEEP SYSTEM (K022037)Excel Tech. , Ltd.2002-09-10
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM (K021807)Grass Instrument Co.2002-08-29
PSG INPUT BOX, MODEL JE-912AK (K022121)Nihon Kohden America, Inc.2002-07-29
NERVUS MONITOR (K021185)Taugagreining HF2002-07-12
TWIN PLUS (K012976)Grass-Telefactor Divison2002-02-12
NOTTA AMBULATORY RECORDER (K013450)Stellate Systems2002-01-14
SOMNO STAR & SERIES SLEEP SYSTEM (K012085)Sensor Medics Corp.2001-08-02
HARMONE-SCHWARZER EEG SYSTEM (K010728)Stellate Systems2001-05-21
LIFELINES TRACKIT (K010460)Lifelines , Ltd.2001-05-14
NEUROFAX, MODELS EEG-1100A, EEG-9100A (K011204)Nihon Kohden America, Inc.2001-05-08
COMPUMEDICS SIESTA SYSTEM (K003175)Compumedics Limited2000-12-27
BIO-LOGIC SLEEPSCAN NETLINK (K003681)Bio-Logic Systems Corp.2000-12-21
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (K001013)Airsep Corp.2000-05-16
VITAPORT 3 (K000338)Nihon Kohden America, Inc.2000-04-26
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM (K994142)Grass Instrument Co.2000-03-06
NEUROFAX, MODEL EEG-1100A (K992742)Nihon Kohden America, Inc.1999-10-14
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (K992283)Airsep Corp.1999-08-27
H20- TETHERED OPTION (K992291)Grass-Telefactor Product Group1999-08-06
BIOSACA SYSTEM, MODEL 800 (K991446)Biosys AB (Publ)1999-07-23
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 (K991900)Excel Tech. , Ltd.1999-07-12
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS (K990522)Lamont Medical, Inc.1999-05-19
BIOSACA SYSTEM (K984580)Biosys AB (Publ)1999-03-12
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 (K983072)Nihon Kohden America, Inc.1998-12-01
MODIFICATION TO BIO-LOGIC SLEEPSCAN (K983913)Bio-Logic Systems Corp.1998-11-25
DEEGLITE (K974583)Grass-Telefactor Product Group1998-06-09
H2O (K974587)Grass-Telefactor Product Group1998-03-09
EMBLA (K971813)Ferguson Medical1998-01-16
ALICE 4R SYSTEM (K971867)Healthdyne Technologies, Inc.1997-08-13
GRASS BRAINWAVE SOFTWARE (K970951)Astro-Med, Inc.1997-05-19
MEDILOG MPA-S (K961638)Oxford Instruments Medical Systems1997-01-17
ALICE (K922106)Healthdyne, Inc.1994-07-06
SANDMAN (K934599)Melville Software , Ltd.1994-01-27
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP. (K860458)Oxford Medilog, Inc.1986-08-12
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH (K854665)Nihon Kohden America, Inc.1986-06-05
SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM (K860219)Grass-Telefactor Product Group1986-04-17

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