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510(k) K242306

SignalNED System (Model RE) by Forest Devices, Inc. — Product Code OMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2024
Date Received
August 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Forest Devices, Inc.

  • K251726 — SignalNED System (Model RE) (September 3, 2025)

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)
  • 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)