Cleared Traditional

Okti

K230073 · Compumedics Limited · Neurology

Feb 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K230073 is an FDA 510(k) clearance for the Okti, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Compumedics Limited (Abbotsford, AU). The FDA issued a Cleared decision on February 9, 2023, 30 days after receiving the submission on January 10, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K230073 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2023
Decision Date	February 09, 2023
Days to Decision	30 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