AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC— 510(k) K895517

Name: FDA 510(k) clearance K895517
Creator: U.S. Food and Drug Administration
Published: 1990-01-04

Substantially Equivalent

Aural Technologies, Inc.

FDA 510(k) clearance K895517 for AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC, Substantially Equivalent on 1990-01-04. Applicant: Aural Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Aural Technologies, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1989-09-12
Decision date: 1990-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ESD

view all

K232999 — Lyric4 Hearing Aid2024-04-11
K130790 — LYRIC22013-06-27
K081136 — LYRIC HEARING AID2008-05-08
K021867 — INSOUND XT SERIES HEARING AID2002-11-19
K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)2001-04-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.