Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) → OLV — Standard Polysomnograph With Electroencephalograph # OLV · Standard Polysomnograph With Electroencephalograph _Neurology · 21 CFR 882.1400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV ## Overview - **Product Code:** OLV - **Device Name:** Standard Polysomnograph With Electroencephalograph - **Regulation:** [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 64) Showing 20 most recent of 64 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260585](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K260585.md) | Noxturnal Web | Nox Medical Ehf | Mar 20, 2026 | SESE | | [K242447](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K242447.md) | Falcon HST | Compumedics Limited | Feb 20, 2025 | SESE | | [K241288](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K241288.md) | Noxturnal Web | Nox Medical Ehf | Dec 23, 2024 | SESE | | [K240700](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K240700.md) | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | Dec 8, 2024 | SESE | | [K213007](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K213007.md) | Cerebra Sleep System | Cerebra Medical , Ltd. | Jul 6, 2022 | SESE | | [K201054](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K201054.md) | SOMNOscreen plus | Somnomedics GmbH | Aug 12, 2020 | SESE | | [K192624](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K192624.md) | ApneaTrak | Cadwell Industries, Inc. | Feb 20, 2020 | SESE | | [K181709](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K181709.md) | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. | Nov 16, 2018 | SESE | | [K173868](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K173868.md) | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | Jul 2, 2018 | SESE | | [K173690](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K173690.md) | Grass TWin | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Mar 9, 2018 | SESE | | [K172986](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K172986.md) | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | Dec 19, 2017 | SESE | | [K172711](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K172711.md) | Comet-PLUS | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Nov 3, 2017 | SESE | | [K161650](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K161650.md) | Polysmith Sleep System, Model NTI7593 | Neurotronics, Inc. | Jan 19, 2017 | SESE | | [K142774](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K142774.md) | Polysmith Sleep System | Neurotronics, Inc. | Feb 18, 2015 | SESE | | [K131415](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K131415.md) | LIVE VIEW PANEL (LVP) | Neurotronics, Inc. | Aug 9, 2013 | SESE | | [K111055](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K111055.md) | GALAXY SYSTEM; JUPITER | Personal Health Institute International | Dec 21, 2011 | SESE | | [K101830](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K101830.md) | ZMACHINE, MODEL DT-100 | Consolidated Research of Richmond, Inc. | Mar 31, 2011 | SESE | | [K093728](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K093728.md) | BE MICRO, TREA | Eb Neuro S.P.A. | Apr 29, 2010 | SESE | | [K073491](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K073491.md) | EEG-1100A SWITCH BOX | Nihon Kohden America, Inc. | Jan 11, 2008 | SESE | | [K071782](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV/K071782.md) | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES | Micromed S.P.A. | Jan 10, 2008 | SESE | ## Top Applicants - Nihon Kohden America, Inc. — 9 clearances - Neurotronics, Inc. — 5 clearances - Grass-Telefactor Product Group — 4 clearances - Bio-Logic Systems Corp. — 3 clearances - Airsep Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLV) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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