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510(k) K232779

QUEX ED; QUEX S by Qx World, Ltd. — Product Code OMC

K232779 is an FDA 510(k) premarket notification submitted by Qx World, Ltd. for the device "QUEX ED; QUEX S". The FDA issued a decision of Substantially Equivalent on October 11, 2024. The device falls under product code OMC (Reduced- Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2024
Date Received
September 11, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reduced- Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

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

Other clearances for product code OMC

  • K261101 — Ceribell Monitor (June 30, 2026)
  • K251550 — NX01 (NX01) (November 25, 2025)
  • K251726 — SignalNED System (Model RE) (September 3, 2025)
  • K243185 — REMI Remote EEG Monitoring System (March 21, 2025)
  • K242930 — Natus BrainWatch System (November 19, 2024)
  • K242306 — SignalNED System (Model RE) (September 4, 2024)
  • K230933 — REMI Remote EEG Monitoring System (June 30, 2023)
  • K223628 — NEBA® Compact EEG2R Mobile Headset (March 2, 2023)
  • K221563 — Neurosteer EEG Recorder (October 24, 2022)
  • K203827 — REMI (March 29, 2021)

FDA data resources