NEAT 001— 510(k) K250058

Substantially Equivalent

Brain Electrophysiology Laboratory Company, LLC

FDA 510(k) clearance K250058 for NEAT 001, Substantially Equivalent on 2025-04-10. Applicant: Brain Electrophysiology Laboratory Company, LLC. Device class: 2.

Clearance details

Applicant
Brain Electrophysiology Laboratory Company, LLC
Product code
Code OLZ
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eugene, OR, US
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