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Smart Tone

by Benson Medical Instruments Co.

Smart Tone is a Class II device made by Benson Medical Instruments Co., listed in FDA GUDID since 16 Sep 2016 (UDI-DI B2075003220), 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 NumberB2075003220 UDI-DI Date16 Sep 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  • Withdrawn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

Generic name
Tone audiometer, automated
Model / Ref / Catalog
SMART TONE
Primary DI / UDI-DI
B2075003220
FDA product code
EWO
GMDN term
Tone audiometer, automated
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tone audiometer, automated

Similar devices

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

Other devices from Benson Medical Instruments Co.

See all devices from Benson Medical Instruments Co. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)