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U.S. Department of Health and Human Services

Product Classification

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Device brain injury adjunctive interpretive electroencephalograph assessment aid
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.
Physical State Handheld EEG recording device, electrodes, and data analysis software
Technical Method Software analysis of EEG signals
Target Area Forehead, scalp
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePIW
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible