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Otometrics Madsen A450

by Natus Medical Denmark ApS 3 variants

Otometrics Madsen A450 (8-04-14561) is a Class II device made by Natus Medical Denmark ApS, listed in FDA GUDID since 7 Jun 2017 (UDI-DI 05713315005961), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713315005961 UDI-DI Date7 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Otometrics
Generic name
Tone audiometer
Model / Ref / Catalog
Madsen A450, 8-04-14561
Primary DI / UDI-DI
05713315005961
FDA product code
EWO
GMDN term
Tone audiometer
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tone audiometerSpeech audiometer

Similar devices

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

Other devices from Natus Medical Denmark ApS

See all devices from Natus Medical Denmark ApS →

Properties

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