510(k) K161068
K161068 is an FDA 510(k) premarket notification submitted by Brainscope Company, Inc. for the device "Ahead 300". The FDA issued a decision of Substantially Equivalent on September 22, 2016. 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
- September 22, 2016
- Date Received
- April 15, 2016
- 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.