Product code OMC
- Device name
- Reduced- Montage Standard 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
- Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
- Source
- FDA openFDA device classification dataset
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| K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | 2024-09-04 |
| K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023-06-30 |
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| K192549 | Byteflies Kit | Byteflies NV | 2020-06-22 |
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| K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017-05-08 |
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| K131944 | IEEG | Jordan Neuroscience, Inc. | 2014-04-10 |
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| K060523 | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM | Cyberkinetics, Inc. | 2006-03-28 |
| K042309 | BIOSOMNIA-V3 | Oxford Biosignals Limited | 2004-09-08 |
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