Cleared Traditional

NeuroField Analysis Suite

K240420 · Neurofield, Inc. · Neurology
Sep 2024
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K240420 is an FDA 510(k) clearance for the NeuroField Analysis Suite, a Normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLU), submitted by Neurofield, Inc. (Bishop, US). The FDA issued a Cleared decision on September 20, 2024, 220 days after receiving the submission on February 13, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K240420 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2024
Decision Date September 20, 2024
Days to Decision 220 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLU — Normalizing Quantitative Electroencephalograph Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User.