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Fonix 8000

by Frye Electronics, Inc.

Fonix 8000 is a Class II device made by Frye Electronics, Inc., listed in FDA GUDID since 22 Aug 2016 (UDI-DI FONIX8000), 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 NumberFONIX8000 UDI-DI Date22 Aug 2016ListedStatusListed 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  • Withdrawn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
Hearing aid tester, electrical
Model / reference
8000
Primary DI / UDI-DI
FONIX8000
FDA product code
ETW
GMDN term
Hearing aid tester, electrical
Device class
Class II
Regulation number
874.3310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hearing aid tester, electrical

Similar devices

Other devices filed under FDA product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems).

Other devices from Frye Electronics, Inc.

See all devices from Frye Electronics, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)