Home / 510(k) Clearances / K221963

510(k) K221963

Cumulus Functional Neurophysiology Platform by Cumulus Neuroscience Limited — Product Code GWQ

K221963 is an FDA 510(k) premarket notification submitted by Cumulus Neuroscience Limited for the device "Cumulus Functional Neurophysiology Platform". The FDA issued a decision of Substantially Equivalent on April 27, 2023. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2023
Date Received
July 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-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 full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances for product code GWQ

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • K260455 — New Wave System (March 13, 2026)
  • K233403 — Flexset System (April 30, 2024)
  • K231366 — Neuronaute Plus (November 9, 2023)
  • K221959 — Q21 (August 31, 2023)
  • K231457 — SPARK Scan (August 18, 2023)
  • K230073 — Okti (February 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
  • K220056 — iSyncWave (August 10, 2022)
  • K212788 — Seer Home (June 16, 2022)

FDA data resources