K181785 is an FDA 510(k) clearance for the Modified BrainScope One. 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 Cleared decision on December 19, 2018, 169 days after receiving the submission on July 3, 2018.
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 | K181785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2018 |
| Decision Date | December 19, 2018 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |