Standard Polysomnograph With Electroencephalograph
Regulation 882.1400
2510(k)s in 12 months (65 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OLV
| Company | 510(k)s | Recalls |
|---|---|---|
| Nihon Kohden America, Inc. | 9 | 0 |
| Neurotronics, Inc. | 5 | 0 |
| Grass-Telefactor Product Group | 4 | 0 |
| Bio-Logic Systems Corp. | 3 | 0 |
| Airsep Corp. | 2 | 0 |
| Astro-Med, Inc. | 2 | 0 |
| Biosys AB (Publ) | 2 | 0 |
| Compumedics Limited | 2 | 0 |
| Excel Tech. , Ltd. | 2 | 0 |
| Grass Instrument Co. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2026 | K261747 | Report Studio Beacon Biosignals, Inc. | OLV |
| Mar 20, 2026 | K260585 | Noxturnal Web Nox Medical Ehf, IS | OLV |
| Feb 20, 2025 | K242447 | Falcon HST Compumedics Limited, AU | OLV |
| Dec 23, 2024 | K241288 | Noxturnal Web Nox Medical Ehf, IS | OLV |
| Dec 8, 2024 | K240700 | HomeSleepTest (HST, HST REM+) Somnomedics GmbH, DE | OLV |
| Jul 6, 2022 | K213007 | Cerebra Sleep System Cerebra Medical , Ltd., CA | OLV |
| Aug 12, 2020 | K201054 | SOMNOscreen plus Somnomedics GmbH, DE | OLV |
| Feb 20, 2020 | K192624 | ApneaTrak Cadwell Industries, Inc. | OLV |
| Nov 16, 2018 | K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor Neurotronics, Inc. | OLV |
| Jul 2, 2018 | K173868 | Serenity Body Position Sensor, Serenity RIP Sensors Neurotronics, Inc. | OLV |
| Mar 9, 2018 | K173690 | Grass TWin Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OLV |
| Dec 19, 2017 | K172986 | Zmachine Synergy Consolidated Research of Richmond, Inc. Dba General Sleep CO | OLV |
| Nov 3, 2017 | K172711 | Comet-PLUS Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OLV |
| Jan 19, 2017 | K161650 | Polysmith Sleep System, Model NTI7593 Neurotronics, Inc. | OLV |
| Feb 18, 2015 | K142774 | Polysmith Sleep System Neurotronics, Inc. | OLV |
| Aug 9, 2013 | K131415 | LIVE VIEW PANEL (LVP) Neurotronics, Inc. | OLV |
| Dec 21, 2011 | K111055 | GALAXY SYSTEM; JUPITER Personal Health Institute International | OLV |
| Mar 31, 2011 | K101830 | ZMACHINE, MODEL DT-100 Consolidated Research of Richmond, Inc. | OLV |
| Apr 29, 2010 | K093728 | BE MICRO, TREA Eb Neuro S.P.A. | OLV |
| Jan 11, 2008 | K073491 | EEG-1100A SWITCH BOX Nihon Kohden America, Inc. | OLV |
| Jan 10, 2008 | K071782 | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES Micromed S.P.A., IT | OLV |
| Oct 20, 2005 | K050425 | AURA-PSG Astro-Med, Inc. | OLV |
| Aug 26, 2005 | K052066 | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER Bio-Logic Systems Corp. | OLV |
| Apr 29, 2005 | K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A Nihon Kohden America, Inc. | OLV |
| Feb 1, 2005 | K050143 | OMNIPRO SYSTEM Mays and Associates, Inc. | OLV |
| Nov 17, 2004 | K042039 | FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 Cleveland Medical Devices, Inc. | OLV |
| Sep 30, 2004 | K042364 | PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES Lamont Medical, Inc. | OLV |
| Jan 7, 2004 | K033475 | WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES Nihon Kohden America, Inc. | OLV |
| May 1, 2003 | K031202 | MEDIPALM-20 Braebon Medical Corp., CA | OLV |
| Dec 31, 2002 | K022249 | NIGHTRON POLYSOMNOGRAPHY SYSTEM Telediagnostic Systems, Inc. | OLV |
| Sep 10, 2002 | K022037 | XLTEK SLEEP SYSTEM Excel Tech. , Ltd., CA | OLV |
| Aug 29, 2002 | K021807 | GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM Grass Instrument Co. | OLV |
| Jul 29, 2002 | K022121 | PSG INPUT BOX, MODEL JE-912AK Nihon Kohden America, Inc. | OLV |
| Jul 12, 2002 | K021185 | NERVUS MONITOR Taugagreining HF | OLV |
| Feb 12, 2002 | K012976 | TWIN PLUS Grass-Telefactor Divison | OLV |
| Jan 14, 2002 | K013450 | NOTTA AMBULATORY RECORDER Stellate Systems, CA | OLV |
| Aug 2, 2001 | K012085 | SOMNO STAR & SERIES SLEEP SYSTEM Sensor Medics Corp. | OLV |
| May 21, 2001 | K010728 | HARMONE-SCHWARZER EEG SYSTEM Stellate Systems, CA | OLV |
| May 14, 2001 | K010460 | LIFELINES TRACKIT Lifelines , Ltd. | OLV |
| May 8, 2001 | K011204 | NEUROFAX, MODELS EEG-1100A, EEG-9100A Nihon Kohden America, Inc. | OLV |
| Dec 27, 2000 | K003175 | COMPUMEDICS SIESTA SYSTEM Compumedics Limited | OLV |
| Dec 21, 2000 | K003681 | BIO-LOGIC SLEEPSCAN NETLINK Bio-Logic Systems Corp. | OLV |
| May 16, 2000 | K001013 | MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY Airsep Corp. | OLV |
| Apr 26, 2000 | K000338 | VITAPORT 3 Nihon Kohden America, Inc. | OLV |
| Mar 6, 2000 | K994142 | GRASS TS3201/6401 EEG AMPLIFIER SYSTEM Grass Instrument Co. | OLV |
| Oct 14, 1999 | K992742 | NEUROFAX, MODEL EEG-1100A Nihon Kohden America, Inc. | OLV |
| Aug 27, 1999 | K992283 | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY Airsep Corp. | OLV |
| Aug 6, 1999 | K992291 | H20- TETHERED OPTION Grass-Telefactor Product Group | OLV |
| Jul 23, 1999 | K991446 | BIOSACA SYSTEM, MODEL 800 Biosys AB (Publ) | OLV |
| Jul 12, 1999 | K991900 | XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 Excel Tech. , Ltd., CA | OLV |
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