510(k) DEN250002

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

August 20, 2025

Date Received

January 3, 2025

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Non-Invasive Evoked Response Brain Stimulator

Device Class

Class II

Regulation Number

882.1860

Review Panel

NE

Submission Type

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.