Product code OMA
- Device name
- Amplitude-Integrated Electroencephalograph
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1400
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192889 | Neo | Eemagine Medical Imaging Solutions GmbH | 2020-01-30 |
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | 2017-05-19 |
| K161027 | Cadwell AmpliScan | Cadwell Industries, Inc. | 2016-11-08 |
| K152301 | Background Pattern Classification [BPc(TM)] | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-06-03 |
| K130238 | NIHON KOHDEN AE-918P NEURO UNIT | Nihon Kohden Corp. | 2015-03-04 |
| K131789 | CEREBRALOGIK- AEEG | Mennen Medical , Ltd. | 2013-12-27 |
| K123079 | OLYMPIC BRAINZ MONITOR | Excel-Tech Ltd. (Xltek) | 2013-05-08 |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | Nihon Kohden America, Inc. | 2012-03-16 |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | Nihon Kohden America, Inc. | 2010-07-09 |
| K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | Natus Medical, Inc. | 2010-06-16 |
| K081551 | TWIN NEUROTRAC-III | Astro-Med, Inc. | 2008-12-24 |
| K080217 | COMPONENT NEUROMONITORING SYSTEM | Moberg Research, Inc. | 2008-11-05 |
| K071449 | BRM3 BRAIN MONITOR | Brainz Instruments , Ltd. | 2007-09-14 |
| K031149 | OLYMPIC CFM 6000 | Olympic Medical Corp. | 2003-05-14 |
| K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | Olympic Medical Corp. | 1999-03-23 |
| K791580 | CEREBRAL FUNCTION MONITOR 870 | Applied Medical Research | 1979-09-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09120109830269 | encevis | AIT Austrian Institute of Technology GmbH | 2025-08-05 |
| 10197106549971 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-02-12 |
| B485CNSENV1000 | CNS Envision | NATUS NEUROLOGY INCORPORATED | 2023-08-18 |
| 09120109830122 | encevis | AIT Austrian Institute of Technology GmbH | 2022-07-15 |
| 00382830007450 | Natus | XLTEK | 2021-10-07 |
| 00382830058209 | Natus | XLTEK | 2021-04-20 |
| B485CNSPTZ3501 | Component Monitoring System | MOBERG RESEARCH INC | 2021-04-19 |
| B485CNS3501 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2021-02-12 |
| 09120109830078 | encevis | AIT Austrian Institute of Technology GmbH | 2021-01-11 |
| B485CNSVID3501 | Component Monitoring System | MOBERG RESEARCH INC | 2020-10-31 |
| B485VIS100 | CNS Envision | MOBERG RESEARCH INC | 2020-10-28 |
| B485CNSVID3701 | Component Monitoring System | MOBERG RESEARCH INC | 2020-10-23 |
| B485CNSPTZ3001 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2019-03-22 |
| B485CNSPTZ3101 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2019-03-22 |
| B485CNSINX3001 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2018-06-06 |
| B485CNSINX3101 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2018-06-06 |
| B485CNSINX3201 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2018-06-06 |
| B485CNS3201 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSEEG2101 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNS3001 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSVID3201 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSVID3101 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSVID3001 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSEEG2001 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNS3101 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSEEG3201 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSEEG3101 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSEEG3001 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| B485CNSEEG2201 | Component Neuromonitoring System | MOBERG RESEARCH INC | 2017-12-21 |
| 00382830053839 | Olympic CFM | NATUS MEDICAL INCORPORATED | 2017-03-31 |