FDA product code PIW

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Neurology·Class 2·21 CFR 882.1450
US regulatory classifications
US Product Code (FDA)
PIW
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.1450
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.