FDA product code SFN

Non-Invasive Evoked Response Brain Stimulator

Neurology·Class 2·21 CFR 882.1860
US regulatory classifications
US Product Code (FDA)
SFN
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.1860
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A non-invasive evoked response brain stimulator is a non-penetrating device used to apply a stimulus to the brain for the purpose of measuring the evoked brain activity response.

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About this record

Non-Invasive Evoked Response Brain Stimulator 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.