OLV — Standard Polysomnograph With Electroencephalograph Class II
FDA product code OLV covers "Standard Polysomnograph With Electroencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260585 | nox medical ehf | Noxturnal Web | March 20, 2026 |
| 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 |