DEN140025 is an FDA 510(k) submission for the BrainScope Ahead 100. This device is classified as a Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid (Class II - Special Controls, product code PIW).
Submitted by Brainscope Company, Inc. (Bethesda, US). The FDA issued a Not Cleared (DENG) decision on November 17, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1450. 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 As An Adjunct To Standard Clinical Practice Only As An Assessment Aid For A Medical Condition For Which There Exists Other Valid Methods Of Diagnosis..
| 510(k) Number | DEN140025 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 20, 2014 |
| Decision Date | November 17, 2014 |
| Days to Decision | 89 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | PIW - Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1450 |
| 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 As An Adjunct To Standard Clinical Practice Only As An Assessment Aid For A Medical Condition For Which There Exists Other Valid Methods Of Diagnosis. |