510(k) K223628

NEBA® Compact EEG2R Mobile Headset by Neba Health, LLC — Product Code OMC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 2, 2023
Date Received: December 5, 2022
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

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)
K232779 — QUEX ED; QUEX S (October 11, 2024)
K242306 — SignalNED System (Model RE) (September 4, 2024)
K230933 — REMI Remote EEG Monitoring System (June 30, 2023)
K221563 — Neurosteer EEG Recorder (October 24, 2022)
K203827 — REMI (March 29, 2021)
K192549 — Byteflies Kit (June 22, 2020)