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Fonix Colt

by Frye Electronics, Inc.

Fonix Colt is a Class II device made by Frye Electronics, Inc., listed in FDA GUDID since 11 Feb 2017 (UDI-DI B191FONIXCOLT0), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB191FONIXCOLT0 UDI-DI Date11 Feb 2017ListedStatusListed 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  • Withdrawn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
Fonix
Generic name
Speech audiometer
Model / reference
Colt
Primary DI / UDI-DI
B191FONIXCOLT0
FDA product code
EWO
GMDN term
Speech audiometer
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Speech audiometerTone audiometer, manual

Similar devices

Other devices filed under FDA product code EWO (Audiometer).

Other devices from Frye Electronics, Inc.

See all devices from Frye Electronics, Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)