OLV · Standard Polysomnograph With Electroencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OLV |
|---|---|
| Device Name | Standard Polysomnograph With Electroencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | Noxturnal Web | Nox Medical Ehf | Mar 20, 2026 | SESE |
| K242447 | Falcon HST | Compumedics Limited | Feb 20, 2025 | SESE |
| K241288 | Noxturnal Web | Nox Medical Ehf | Dec 23, 2024 | SESE |
| K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | Dec 8, 2024 | SESE |
| K213007 | Cerebra Sleep System | Cerebra Medical , Ltd. | Jul 6, 2022 | SESE |
| K201054 | SOMNOscreen plus | Somnomedics GmbH | Aug 12, 2020 | SESE |
| K192624 | ApneaTrak | Cadwell Industries, Inc. | Feb 20, 2020 | SESE |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. | Nov 16, 2018 | SESE |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | Jul 2, 2018 | SESE |
| K173690 | Grass TWin | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Mar 9, 2018 | SESE |
| K172986 | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | Dec 19, 2017 | SESE |
| K172711 | Comet-PLUS | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Nov 3, 2017 | SESE |
| K161650 | Polysmith Sleep System, Model NTI7593 | Neurotronics, Inc. | Jan 19, 2017 | SESE |
| K142774 | Polysmith Sleep System | Neurotronics, Inc. | Feb 18, 2015 | SESE |
| K131415 | LIVE VIEW PANEL (LVP) | Neurotronics, Inc. | Aug 9, 2013 | SESE |
| K111055 | GALAXY SYSTEM; JUPITER | Personal Health Institute International | Dec 21, 2011 | SESE |
| K101830 | ZMACHINE, MODEL DT-100 | Consolidated Research of Richmond, Inc. | Mar 31, 2011 | SESE |
| K093728 | BE MICRO, TREA | Eb Neuro S.P.A. | Apr 29, 2010 | SESE |
| K073491 | EEG-1100A SWITCH BOX | Nihon Kohden America, Inc. | Jan 11, 2008 | SESE |
| K071782 | 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
