Audioscan Axiom

by Etymonic Design Incorporated

Audioscan Axiom is a Class II device made by Etymonic Design Incorporated, listed in FDA GUDID since 23 Sep 2016 (UDI-DI B161AXIOM0), 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB161AXIOM0 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Audioscan
Generic name: Audiometric/hearing aid tester
Model / reference: Axiom

Primary DI / UDI-DI: B161AXIOM0
FDA product code: ETW
GMDN term: Audiometric/hearing aid tester

Device class: Class II
Regulation number: 874.3310
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Audiometric/hearing aid tester.

Other devices from Etymonic Design Incorporated

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Audioscan RM500SL

Class II

Properties

Premarket exempt
Serial number

Other properties (13, all answered No)