510(k) K183241
K183241 is an FDA 510(k) premarket notification submitted by Brainscope Company, Inc. for the device "BrainScope TBI (Model: Ahead 400)". The FDA issued a decision of Substantially Equivalent on February 19, 2019. The device falls under product code PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid), a Class II device regulated under 21 CFR 882.1450. Brainscope Company, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 2019
- Date Received
- November 21, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.1450
- Review Panel
- NE
- Submission Type
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.