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
| Device Type ID | 3774 |
| Device Name | Reduced- Montage Standard Electroencephalograph |
| Physical State | May Include Standard EEG Recording Hardware (e.g. Headbox, Cables, CPU, Monitor And Basic Software (needed To Display, Store And Archive EEG And Allow User-only Annotation And Marking); Does NOT Include Electrodes, More Complex Software Used To Analy |
| Technical Method | Uses Electrodes (less Than < 16) Placed On The Scalp Or Within The Brain, Via User-specified And/or Sponsor-specified Locations, To Record And Display Electrical Activity Of The Brain |
| Target Area | Brain |
| Regulation Description | Electroencephalograph. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
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| Device Type ID | 3774 |
| Device | Reduced- Montage Standard Electroencephalograph |
| Product Code | OMC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED BRAIN MONITORING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CERIBELL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JORDAN NEUROSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |