Skip to content

WAVi Scan Software SW100

by Wavi Co.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB592SW100 UDI-DI Date25 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
WAVi Scan Software
Generic Name
Electroencephalograph
Model / Reference
SW100
Primary DI / UDI-DI
B592SW100
510(k) Number
FDA Product Code
GWQ, GWJ, OLT
GMDN Term
Electroencephalograph
Device Class
Class II
Regulation Number
882.1400, 882.1900
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K213900)

Other devices from Wavi Co.

See all devices from Wavi Co. →

Properties

  • Lot / Batch Number

Other properties (13)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No