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Etymotic ER38-50HT

by Etymotic Research, Inc.

Etymotic ER38-50HT is a tone audiometer (FDA Class II; FDA product code EWO, Audiometer) made by Etymotic Research, Inc., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00846430004016), 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 Number00846430004016 UDI-DI Date19 Sep 2016ListedStatusListed 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  • Withdrawn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
Etymotic
Generic name
Tone audiometer
Model / reference
ER38-50HT
Primary DI / UDI-DI
00846430004016
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 audiometer

Similar devices in this category

Other devices filed under Tone audiometer.

Other devices from Etymotic Research, Inc.

See all devices from Etymotic Research, Inc. →

Properties

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