Definition: A Prescription Device That Uses A Patient¿s Electroencephalograph (EEG) To Provide An Interpretation Of The Structural Condition Of The Patient¿s Brain In The Setting Of Trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid Is For Use A
| Device Type ID | 3782 |
| Device Name | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Physical State | Handheld EEG Recording Device, Electrodes, And Data Analysis Software |
| Technical Method | Software Analysis Of EEG Signals |
| Target Area | Forehead, Scalp |
| Regulation Description | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid. |
| 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 | 882.1450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3782 |
| Device | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Product Code | PIW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid. |
| CFR Regulation Number | 882.1450 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRAINSCOPE COMPANY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |