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510(k) K192549

Byteflies Kit by Byteflies NV — Product Code OMC

K192549 is an FDA 510(k) premarket notification submitted by Byteflies NV for the device "Byteflies Kit". The FDA issued a decision of Substantially Equivalent on June 22, 2020. 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
June 22, 2020
Date Received
September 17, 2019
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)
  • K221563 — Neurosteer EEG Recorder (October 24, 2022)

FDA data resources