Audiometer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810583 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Middle Ear Analyzer (Impedance Audiometer)

  Class II

  FDA 510(k) K863353 Active Cleared 3 Nov 1986

• Middle Ear Analyzer (Impedance Audio

  Class II

  FDA 510(k) K820715 Active Cleared 9 Apr 1982

• Middle Ear Analyzer (Imped. Audiomtr)

  Class II

  FDA 510(k) K790846 Active Cleared 17 May 1979

• GSI Novus

  Class II

  FDA 510(k) K172403 Active Cleared 20 Oct 2017

• The Screener Gsi 55 Abr Screener

  Class II

  FDA 510(k) K870030 Active Cleared 13 Mar 1987

• GSI Audera Pro

  Class II

  FDA 510(k) K193033 Active Cleared 24 Apr 2020

See all devices from Grason-Stadler, Inc. →