Product code OLV
- Device name
- Standard Polysomnograph With Electroencephalograph
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1400
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260585 | Noxturnal Web | Nox Medical Ehf | 2026-03-20 |
| K242447 | Falcon HST | Compumedics Limited | 2025-02-20 |
| K241288 | Noxturnal Web | Nox Medical Ehf | 2024-12-23 |
| K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | 2024-12-08 |
| K213007 | Cerebra Sleep System | Cerebra Medical , Ltd. | 2022-07-06 |
| K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020-08-12 |
| K192624 | ApneaTrak | Cadwell Industries, Inc. | 2020-02-20 |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. | 2018-11-16 |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018-07-02 |
| K173690 | Grass TWin | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-09 |
| K172986 | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | 2017-12-19 |
| K172711 | Comet-PLUS | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2017-11-03 |
| K161650 | Polysmith Sleep System, Model NTI7593 | Neurotronics, Inc. | 2017-01-19 |
| K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015-02-18 |
| K131415 | LIVE VIEW PANEL (LVP) | Neurotronics, Inc. | 2013-08-09 |
| K111055 | GALAXY SYSTEM; JUPITER | Personal Health Institute International | 2011-12-21 |
| K101830 | ZMACHINE, MODEL DT-100 | Consolidated Research of Richmond, Inc. | 2011-03-31 |
| K093728 | BE MICRO, TREA | Eb Neuro S.P.A. | 2010-04-29 |
| K073491 | EEG-1100A SWITCH BOX | Nihon Kohden America, Inc. | 2008-01-11 |
| K071782 | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES | Micromed S.P.A. | 2008-01-10 |
| K050425 | AURA-PSG | Astro-Med, Inc. | 2005-10-20 |
| K052066 | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER | Bio-Logic Systems Corp. | 2005-08-26 |
| K050833 | ELECTRODE JUNCTION BOX, MODEL JE-921A | Nihon Kohden America, Inc. | 2005-04-29 |
| K050143 | OMNIPRO SYSTEM | Mays and Associates, Inc. | 2005-02-01 |
| K042039 | FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 | Cleveland Medical Devices, Inc. | 2004-11-17 |
| K042364 | PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES | Lamont Medical, Inc. | 2004-09-30 |
| K033475 | WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES | Nihon Kohden America, Inc. | 2004-01-07 |
| K031202 | MEDIPALM-20 | Braebon Medical Corp. | 2003-05-01 |
| K022249 | NIGHTRON POLYSOMNOGRAPHY SYSTEM | Telediagnostic Systems, Inc. | 2002-12-31 |
| K022037 | XLTEK SLEEP SYSTEM | Excel Tech. , Ltd. | 2002-09-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056446901335 | BE PLUS PRO [FULL] | EB NEURO SPA | 2024-12-04 |
| 08056446901328 | BE PLUS PRO [STANDARD] | EB NEURO SPA | 2024-12-04 |
| 08056446901311 | BE PLUS PRO [LIGHT] | EB NEURO SPA | 2024-12-04 |
| 08056446901342 | BE PLUS PRO [ADVANCED] | EB NEURO SPA | 2024-12-04 |
| 08056446900673 | Neurotravel LIGHT | EB NEURO SPA | 2024-12-04 |
| 08720256698036 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698005 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698012 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698029 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698159 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698043 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698050 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698067 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698074 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698098 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698111 | Onera STS | Onera B.V. | 2023-03-15 |
| 08720256698135 | Onera STS | Onera B.V. | 2023-03-15 |
| 08056446900642 | Galileo NT Line Software | EB NEURO SPA | 2020-05-25 |
| 08056446900956 | BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL | EB NEURO SPA | 2019-04-02 |
| 08056446900055 | BE Micro Headbox | EB NEURO SPA | 2019-04-02 |
| 08056446900048 | BE Micro PLUG-IN HEADBOX | EB NEURO SPA | 2019-04-02 |
| 08056446900024 | BE Micro USB BRIDGE | EB NEURO SPA | 2019-04-02 |
| 08056446900017 | BE Micro Recorder | EB NEURO SPA | 2019-04-02 |
| 08056446900000 | BE Micro | EB NEURO SPA | 2019-04-01 |
| 08033928120903 | Micromed | MICROMED SPA | 2018-05-21 |
| 08033928120897 | Micromed | MICROMED SPA | 2018-05-21 |
| 08033928120798 | micromed | MICROMED SPA | 2018-03-21 |
| 08033928120750 | micromed | MICROMED SPA | 2018-03-21 |
| 08033928120743 | micromed | MICROMED SPA | 2018-03-21 |
| 08033928120736 | micromed | MICROMED SPA | 2018-03-21 |