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510(k) K221563

Neurosteer EEG Recorder by Neurosteer, Inc. — Product Code OMC

K221563 is an FDA 510(k) premarket notification submitted by Neurosteer, Inc. for the device "Neurosteer EEG Recorder". The FDA issued a decision of Substantially Equivalent on October 24, 2022. 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 24, 2022
Date Received
May 31, 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

  • 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)
  • 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)
  • K203827 — REMI (March 29, 2021)

FDA data resources