FDA Product Code
FDA Product Code OLV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261747 | Report Studio | Beacon Biosignals, Inc. | 2026-08-25 | Traditional | PDF ↗ |
| K260585 | Noxturnal Web | Nox Medical Ehf | 2026-03-20 | Special | PDF ↗ |
| K242447 | Falcon HST | Compumedics Limited | 2025-02-20 | Traditional | PDF ↗ |
| K241288 | Noxturnal Web | Nox Medical Ehf | 2024-12-23 | Traditional | PDF ↗ |
| K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | 2024-12-08 | Traditional | PDF ↗ |
| K213007 | Cerebra Sleep System | Cerebra Medical , Ltd. | 2022-07-06 | Traditional | PDF ↗ |
| K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020-08-12 | Traditional | PDF ↗ |
| K192624 | ApneaTrak | Cadwell Industries, Inc. | 2020-02-20 | Traditional | PDF ↗ |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. | 2018-11-16 | Traditional | PDF ↗ |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018-07-02 | Traditional | PDF ↗ |
| K173690 | Grass TWin | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-09 | Special | PDF ↗ |
| K172986 | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | 2017-12-19 | Traditional | PDF ↗ |
| K172711 | Comet-PLUS | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2017-11-03 | Special | PDF ↗ |
| K161650 | Polysmith Sleep System, Model NTI7593 | Neurotronics, Inc. | 2017-01-19 | Traditional | PDF ↗ |
| K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015-02-18 | Traditional | PDF ↗ |
| K131415 | LIVE VIEW PANEL (LVP) | Neurotronics, Inc. | 2013-08-09 | Traditional | PDF ↗ |
| K111055 | GALAXY SYSTEM; JUPITER | Personal Health Institute International | 2011-12-21 | Traditional | PDF ↗ |
| K101830 | ZMACHINE, MODEL DT-100 | Consolidated Research of Richmond, Inc. | 2011-03-31 | Traditional | PDF ↗ |
| K093728 | BE MICRO, TREA | Eb Neuro S.P.A. | 2010-04-29 | Traditional | PDF ↗ |
| K073491 | EEG-1100A SWITCH BOX | Nihon Kohden America, Inc. | 2008-01-11 | Special | PDF ↗ |
| K071782 | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES | Micromed S.P.A. | 2008-01-10 | Abbreviated | PDF ↗ |
| K050425 | AURA-PSG | Astro-Med, Inc. | 2005-10-20 | Traditional | PDF ↗ |
| K052066 | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER | Bio-Logic Systems Corp. | 2005-08-26 | Special | PDF ↗ |
| K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A | Nihon Kohden America, Inc. | 2005-04-29 | Special | PDF ↗ |
| K050143 | OMNIPRO SYSTEM | Mays and Associates, Inc. | 2005-02-01 | Traditional | PDF ↗ |
| K042039 | FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 | Cleveland Medical Devices, Inc. | 2004-11-17 | Traditional | PDF ↗ |
| K042364 | PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES | Lamont Medical, Inc. | 2004-09-30 | Special | PDF ↗ |
| K033475 | WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES | Nihon Kohden America, Inc. | 2004-01-07 | Traditional | PDF ↗ |
| K031202 | MEDIPALM-20 | Braebon Medical Corp. | 2003-05-01 | Traditional | PDF ↗ |
| K022249 | NIGHTRON POLYSOMNOGRAPHY SYSTEM | Telediagnostic Systems, Inc. | 2002-12-31 | Traditional | PDF ↗ |
| K022037 | XLTEK SLEEP SYSTEM | Excel Tech. , Ltd. | 2002-09-10 | Special | PDF ↗ |
| K021807 | GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM | Grass Instrument Co. | 2002-08-29 | Traditional | PDF ↗ |
| K022121 | PSG INPUT BOX, MODEL JE-912AK | Nihon Kohden America, Inc. | 2002-07-29 | Special | PDF ↗ |
| K021185 | NERVUS MONITOR | Taugagreining HF | 2002-07-12 | Traditional | PDF ↗ |
| K012976 | TWIN PLUS | Grass-Telefactor Divison | 2002-02-12 | Traditional | PDF ↗ |
| K013450 | NOTTA AMBULATORY RECORDER | Stellate Systems | 2002-01-14 | Abbreviated | PDF ↗ |
| K012085 | SOMNO STAR & SERIES SLEEP SYSTEM | Sensor Medics Corp. | 2001-08-02 | Special | PDF ↗ |
| K010728 | HARMONE-SCHWARZER EEG SYSTEM | Stellate Systems | 2001-05-21 | Abbreviated | PDF ↗ |
| K010460 | LIFELINES TRACKIT | Lifelines , Ltd. | 2001-05-14 | Traditional | PDF ↗ |
| K011204 | NEUROFAX, MODELS EEG-1100A, EEG-9100A | Nihon Kohden America, Inc. | 2001-05-08 | Special | PDF ↗ |
| K003175 | COMPUMEDICS SIESTA SYSTEM | Compumedics Limited | 2000-12-27 | Traditional | PDF ↗ |
| K003681 | BIO-LOGIC SLEEPSCAN NETLINK | Bio-Logic Systems Corp. | 2000-12-21 | Special | PDF ↗ |
| K001013 | MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | Airsep Corp. | 2000-05-16 | Traditional | PDF ↗ |
| K000338 | VITAPORT 3 | Nihon Kohden America, Inc. | 2000-04-26 | Traditional | PDF ↗ |
| K994142 | GRASS TS3201/6401 EEG AMPLIFIER SYSTEM | Grass Instrument Co. | 2000-03-06 | Traditional | PDF ↗ |
| K992742 | NEUROFAX, MODEL EEG-1100A | Nihon Kohden America, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K992283 | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | Airsep Corp. | 1999-08-27 | Traditional | PDF ↗ |
| K992291 | H20- TETHERED OPTION | Grass-Telefactor Product Group | 1999-08-06 | Special | PDF ↗ |
| K991446 | BIOSACA SYSTEM, MODEL 800 | Biosys AB (Publ) | 1999-07-23 | Traditional | PDF ↗ |
| K991900 | XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 | Excel Tech. , Ltd. | 1999-07-12 | Traditional | PDF ↗ |
| K990522 | WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS | Lamont Medical, Inc. | 1999-05-19 | Traditional | PDF ↗ |
| K984580 | BIOSACA SYSTEM | Biosys AB (Publ) | 1999-03-12 | Traditional | PDF ↗ |
| K983072 | AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 | Nihon Kohden America, Inc. | 1998-12-01 | Traditional | PDF ↗ |
| K983913 | MODIFICATION TO BIO-LOGIC SLEEPSCAN | Bio-Logic Systems Corp. | 1998-11-25 | Special | PDF ↗ |
| K974583 | DEEGLITE | Grass-Telefactor Product Group | 1998-06-09 | Traditional | PDF ↗ |
| K974587 | H2O | Grass-Telefactor Product Group | 1998-03-09 | Traditional | PDF ↗ |
| K971813 | EMBLA | Ferguson Medical | 1998-01-16 | Traditional | PDF ↗ |
| K971867 | ALICE 4R SYSTEM | Healthdyne Technologies, Inc. | 1997-08-13 | Traditional | PDF ↗ |
| K970951 | GRASS BRAINWAVE SOFTWARE | Astro-Med, Inc. | 1997-05-19 | Traditional | PDF ↗ |
| K961638 | MEDILOG MPA-S | Oxford Instruments Medical Systems | 1997-01-17 | Traditional | PDF ↗ |
| K922106 | ALICE | Healthdyne, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K934599 | SANDMAN | Melville Software , Ltd. | 1994-01-27 | Traditional | PDF ↗ |
| K860458 | ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP. | Oxford Medilog, Inc. | 1986-08-12 | Traditional | PDF ↗ |
| K854665 | 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH | Nihon Kohden America, Inc. | 1986-06-05 | Traditional | PDF ↗ |
| K860219 | SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM | Grass-Telefactor Product Group | 1986-04-17 | Traditional | PDF ↗ |
Product code OLV · Class II · Neurology. Data: openFDA.