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Evoke EEG System 2.11

by Firefly Neuroscience, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860016073401 UDI-DIDate7 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Evoke EEG System
Generic Name
Electroencephalograph
Model / Reference
2.11
Primary DI / UDI-DI
00860016073401
510(k) Number
FDA Product Code
GWJ, GWQ
GMDN Term
Electroencephalograph
Device Class
Class II
Regulation Number
882.1900, 882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K171781)

Other devices from Firefly Neuroscience, Inc.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No