Amplitude-Integrated Electroencephalograph
FDA product code OMA · Class II (moderate risk) · 21 CFR 882.1400 · Neurology
Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
16510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Olympic Medical Corp. 2
- Nihon Kohden America, Inc. 2
- Nihon Kohden Corporation 2
- Applied Medical Research 1
- Brainz Instruments , Ltd. 1
- Moberg Research, Inc. 1
- Astro-Med, Inc. 1
- Natus Medical Incorporated 1
- Excel-Tech Ltd. (Xltek) 1
- Mennen Medical, Inc. 1
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 1
- Cadwell Industries, Inc. 1
- Eemagine Medical Imaging Solutions GmbH 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192889 | NeoOMA · Traditional | Eemagine Medical Imaging Solutions GmbH | 01/30/2020SE |
| K163644 | Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional | Nihon Kohden Corporation | 05/19/2017SE |
| K161027 | Cadwell AmpliScanOMA · Traditional | Cadwell Industries, Inc. | 11/08/2016SE |
| K152301 | Background Pattern Classification [BPc(TM)]OMA · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 06/03/2016SE |
| K130238 | Nihon Kohden AE-918P Neuro UnitOMA · Traditional | Nihon Kohden Corp. | 03/04/2015SE |
| K131789 | Cerebralogik- AeegOMA · Traditional | Mennen Medical , Ltd. | 12/27/2013SE |
| K123079 | Olympic Brainz MonitorOMA · Traditional | Excel-Tech Ltd. (Xltek) | 05/08/2013SE |
| K120485 | Nihon Kohden QP-160 Ak Trend Program with the Addition of Dsa Asymmetry Trend and FFT POMA · Special | Nihon Kohden America, Inc. | 03/16/2012SE |
| K092573 | Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional | Nihon Kohden America, Inc. | 07/09/2010SE |
| K093949 | Olympic Brainz Monitor Model OBM70001OMA · Traditional | Natus Medical, Inc. | 06/16/2010SE |
| K081551 | Twin Neurotrac-IiiOMA · Traditional | Astro-Med, Inc. | 12/24/2008SE |
| K080217 | Component Neuromonitoring SystemOMA · Traditional | Moberg Research, Inc. | 11/05/2008SE |
| K071449 | BRM3 Brain MonitorOMA · Traditional | Brainz Instruments , Ltd. | 09/14/2007SE |
| K031149 | Olympic CFM 6000OMA · Special | Olympic Medical Corp. | 05/14/2003SE |
| K983229 | Olympic Medical Lectromed Cerebral Function Monitor SystemOMA · Traditional | Olympic Medical Corp. | 03/23/1999SE |
| K791580 | Cerebral Function Monitor 870OMA · Traditional | Applied Medical Research | 09/04/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1925-2025 Class II | Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB…Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately… | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | 05/07/2025Open, Classified |
| Z-1338-2023 Class II | Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term…Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact… | Moberg Research, Inc. | 02/20/2023Open, Classified |
| Z-1630-2020 Class II | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalographThe OBM system functional test (impedance and noise) was not carried out on the affected items prior to… | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | 03/05/2020Terminated |