Cleared Traditional

Q21

K221959 · Neurofield, Inc. · Neurology
Aug 2023
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K221959 is an FDA 510(k) clearance for the Q21, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Neurofield, Inc. (Bishop, US). The FDA issued a Cleared decision on August 31, 2023, 422 days after receiving the submission on July 5, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K221959 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date August 31, 2023
Days to Decision 422 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWQ — Full-montage Standard Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations