Cleared Traditional

QUEX ED; QUEX S

K232779 · Qx World, Ltd. · Neurology

Oct 2024

Decision

396d

Days

Class 2

Risk

About This 510(k) Submission

K232779 is an FDA 510(k) clearance for the QUEX ED; QUEX S, a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Qx World, Ltd. (Budapest, HU). The FDA issued a Cleared decision on October 11, 2024, 396 days after receiving the submission on September 11, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K232779 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2023
Decision Date	October 11, 2024
Days to Decision	396 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMC — Reduced- 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 User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes