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510(k) K243185

REMI Remote EEG Monitoring System by Epitel — Product Code OMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2025
Date Received
September 30, 2024
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 by Epitel

  • K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM) (October 17, 2024)
  • K231779 — REMI AI Discrete Detection Module (January 3, 2024)
  • K230933 — REMI Remote EEG Monitoring System (June 30, 2023)
  • K203827 — REMI (March 29, 2021)

Other clearances for product code OMC

  • K251550 — NX01 (NX01) (November 25, 2025)
  • K251726 — SignalNED System (Model RE) (September 3, 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)
  • K223628 — NEBA® Compact EEG2R Mobile Headset (March 2, 2023)
  • K221563 — Neurosteer EEG Recorder (October 24, 2022)
  • K203827 — REMI (March 29, 2021)
  • K192549 — Byteflies Kit (June 22, 2020)