FDA 510(k) Applications for Medical Device Product Code "OLV"
(Standard Polysomnograph With Electroencephalograph)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K992283 | AIRSEP CORP. | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | 08/27/1999 |
| K001013 | AIRSEP CORP. | MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | 05/16/2000 |
| K050425 | ASTRO-MED, INC. | AURA-PSG | 10/20/2005 |
| K970951 | ASTRO-MED, INC. | GRASS BRAINWAVE SOFTWARE | 05/19/1997 |
| K003681 | BIO-LOGIC SYSTEMS CORP. | BIO-LOGIC SLEEPSCAN NETLINK | 12/21/2000 |
| K052066 | BIO-LOGIC SYSTEMS CORP. | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER | 08/26/2005 |
| K983913 | BIO-LOGIC SYSTEMS CORP. | MODIFICATION TO BIO-LOGIC SLEEPSCAN | 11/25/1998 |
| K984580 | BIOSYS AB (PUBL) | BIOSACA SYSTEM | 03/12/1999 |
| K991446 | BIOSYS AB (PUBL) | BIOSACA SYSTEM, MODEL 800 | 07/23/1999 |
| K031202 | BRAEBON MEDICAL CORP. | MEDIPALM-20 | 05/01/2003 |
| K192624 | Cadwell Industries, Inc. | ApneaTrak | 02/20/2020 |
| K213007 | Cerebra Medical Ltd. | Cerebra Sleep System | 07/06/2022 |
| K042039 | CLEVELAND MEDICAL DEVICES, INC. | FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 | 11/17/2004 |
| K003175 | COMPUMEDICS LIMITED | COMPUMEDICS SIESTA SYSTEM | 12/27/2000 |
| K101830 | CONSOLIDATED RESEARCH OF RICHMOND, INC | ZMACHINE, MODEL DT-100 | 03/31/2011 |
| K172986 | Consolidated Research of Richmond, Inc. dba General Sleep Co | Zmachine Synergy | 12/19/2017 |
| K093728 | EB NEURO, S.P.A. | BE MICRO, TREA | 04/29/2010 |
| K991900 | EXCEL TECH. LTD. | XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 | 07/12/1999 |
| K022037 | EXCEL TECH. LTD. | XLTEK SLEEP SYSTEM | 09/10/2002 |
| K971813 | FERGUSON MEDICAL | EMBLA | 01/16/1998 |
| K994142 | GRASS INSTRUMENT CO. | GRASS TS3201/6401 EEG AMPLIFIER SYSTEM | 03/06/2000 |
| K021807 | GRASS INSTRUMENT CO. | GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM | 08/29/2002 |
| K012976 | GRASS-TELEFACTOR DIVISON | TWIN PLUS | 02/12/2002 |
| K974583 | GRASS-TELEFACTOR PRODUCT GROUP | DEEGLITE | 06/09/1998 |
| K992291 | GRASS-TELEFACTOR PRODUCT GROUP | H20- TETHERED OPTION | 08/06/1999 |
| K974587 | GRASS-TELEFACTOR PRODUCT GROUP | H2O | 03/09/1998 |
| K971867 | HEALTHDYNE TECHNOLOGIES, INC. | ALICE 4R SYSTEM | 08/13/1997 |
| K990522 | LA MONT MEDICAL, INC. | WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS | 05/19/1999 |
| K042364 | LAMONT MEDICAL INC | PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES | 09/30/2004 |
| K010460 | LIFELINES LTD. | LIFELINES TRACKIT | 05/14/2001 |
| K050143 | MAYS AND ASSOCIATES, INC. | OMNIPRO SYSTEM | 02/01/2005 |
| K071782 | MICROMED S.P.A. | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES | 01/10/2008 |
| K172711 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | Comet-PLUS | 11/03/2017 |
| K173690 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | Grass TWin | 03/09/2018 |
| K131415 | NEUROTRONICS, INC. | LIVE VIEW PANEL (LVP) | 08/09/2013 |
| K142774 | Neurotronics, Inc. | Polysmith Sleep System | 02/18/2015 |
| K161650 | Neurotronics, Inc. | Polysmith Sleep System, Model NTI7593 | 01/19/2017 |
| K173868 | Neurotronics, Inc. | Serenity Body Position Sensor, Serenity RIP Sensors | 07/02/2018 |
| K181709 | Neurotronics, Inc. | Serenity Piezo Sensor, Serenity Thermocouple Sensor | 11/16/2018 |
| K983072 | NIHON KOHDEN AMERICA, INC. | AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 | 12/01/1998 |
| K073491 | NIHON KOHDEN AMERICA, INC. | EEG-1100A SWITCH BOX | 01/11/2008 |
| K050833 | NIHON KOHDEN AMERICA, INC. | ELECTRODE JUNCTION BOX, MODEL JE-921A | 04/29/2005 |
| K992742 | NIHON KOHDEN AMERICA, INC. | NEUROFAX, MODEL EEG-1100A | 10/14/1999 |
| K011204 | NIHON KOHDEN AMERICA, INC. | NEUROFAX, MODELS EEG-1100A, EEG-9100A | 05/08/2001 |
| K022121 | NIHON KOHDEN AMERICA, INC. | PSG INPUT BOX, MODEL JE-912AK | 07/29/2002 |
| K000338 | NIHON KOHDEN AMERICA, INC. | VITAPORT 3 | 04/26/2000 |
| K033475 | NIHON KOHDEN AMERICA, INC. | WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES | 01/07/2004 |
| K961638 | OXFORD INSTRUMENTS MEDICAL SYSTEMS | MEDILOG MPA-S | 01/17/1997 |
| K111055 | PERSONAL HEALTH INSTITUTE INTERNATIONAL | GALAXY SYSTEM; JUPITER | 12/21/2011 |
| K012085 | SENSORMEDICS CORP. | SOMNO STAR & SERIES SLEEP SYSTEM | 08/02/2001 |
| K201054 | Somnomedics GmbH | SOMNOscreen plus | 08/12/2020 |
| K010728 | STELLATE SYSTEMS | HARMONE-SCHWARZER EEG SYSTEM | 05/21/2001 |
| K013450 | STELLATE SYSTEMS | NOTTA AMBULATORY RECORDER | 01/14/2002 |
| K021185 | TAUGAGREINING HF | NERVUS MONITOR | 07/12/2002 |
| K022249 | TELEDIAGNOSTIC SYSTEMS, INC. | NIGHTRON POLYSOMNOGRAPHY SYSTEM | 12/31/2002 |
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