Cleared Traditional

Cumulus Functional Neurophysiology Platform

K221963 · Cumulus Neuroscience Limited · Neurology
Apr 2023
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K221963 is an FDA 510(k) clearance for the Cumulus Functional Neurophysiology Platform, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Cumulus Neuroscience Limited (Belfast, IE). The FDA issued a Cleared decision on April 27, 2023, 296 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 K221963 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date April 27, 2023
Days to Decision 296 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