OLV — Standard Polysomnograph With Electroencephalograph Class II
Classification Details
- Product Code
- OLV
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242447 | compumedics limited | Falcon HST | February 20, 2025 |
| K241288 | nox medical ehf | Noxturnal Web | December 23, 2024 |
| K240700 | somnomedics | HomeSleepTest (HST, HST REM+) | December 8, 2024 |
| K213007 | cerebra medical | Cerebra Sleep System | July 6, 2022 |
| K201054 | somnomedics | SOMNOscreen plus | August 12, 2020 |
| K192624 | cadwell industries | ApneaTrak | February 20, 2020 |
| K181709 | neurotronics | Serenity Piezo Sensor, Serenity Thermocouple Sensor | November 16, 2018 |
| K173868 | neurotronics | Serenity Body Position Sensor, Serenity RIP Sensors | July 2, 2018 |
| K173690 | natus medical incorporated dba excel-tech ltd. (xltek) | Grass TWin | March 9, 2018 |
| K172986 | consolidated research of richmond, inc. dba general sleep | Zmachine Synergy | December 19, 2017 |
| K172711 | natus medical incorporated dba excel-tech ltd. (xltek) | Comet-PLUS | November 3, 2017 |
| K161650 | neurotronics | Polysmith Sleep System, Model NTI7593 | January 19, 2017 |
| K142774 | neurotronics | Polysmith Sleep System | February 18, 2015 |
| K131415 | neurotronics | LIVE VIEW PANEL (LVP) | August 9, 2013 |
| K111055 | personal health institute international | GALAXY SYSTEM; JUPITER | December 21, 2011 |
| K101830 | consolidated research of richmond | ZMACHINE, MODEL DT-100 | March 31, 2011 |
| K093728 | eb neuro | BE MICRO, TREA | April 29, 2010 |
| K073491 | nihon kohden america | EEG-1100A SWITCH BOX | January 11, 2008 |
| K071782 | micromed | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES | January 10, 2008 |
| K050425 | astro-med | AURA-PSG | October 20, 2005 |