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 | ||
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Manufacturer | Decision | |
BRAINSCOPE COMPANY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |