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Fonix FP35

by Frye Electronics, Inc.

Fonix FP35 is a Class II device made by Frye Electronics, Inc., listed in FDA GUDID since 22 Aug 2016 (UDI-DI FONIXFP35), 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 NumberFONIXFP35 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  • Withdrawn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
Tone audiometer, manual
Model / reference
FP35
Primary DI / UDI-DI
FONIXFP35
FDA product code
EWO, ETW
GMDN term
Tone audiometer, manual
Device class
Class II
Regulation number
874.1050, 874.3310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hearing aid tester, electricalTone 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

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