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510(k) K223644

Neuronaute with IceCap 2 & IceCap 2 Small by Bioserenity — Product Code GWQ

K223644 is an FDA 510(k) premarket notification submitted by Bioserenity for the device "Neuronaute with IceCap 2 & IceCap 2 Small". The FDA issued a decision of Substantially Equivalent on January 12, 2023. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Bioserenity has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2023
Date Received
December 6, 2022
Clearance Type
Special
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 by Bioserenity

  • K231366 — Neuronaute Plus (November 9, 2023)
  • K202334 — Neuronaute (December 10, 2020)
  • K173248 — CARDIOSKIN (August 11, 2018)
  • K170138 — NEURONAUTE (December 26, 2017)

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)
  • K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
  • K230073 — Okti (February 9, 2023)
  • K220056 — iSyncWave (August 10, 2022)
  • K212788 — Seer Home (June 16, 2022)

FDA data resources