ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA— 510(k) K882471

Name: FDA 510(k) clearance K882471
Creator: U.S. Food and Drug Administration
Published: 1988-08-26

Substantially Equivalent

Ear Tech, Inc.

FDA 510(k) clearance K882471 for ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA, Substantially Equivalent on 1988-08-26. Applicant: Ear Tech, Inc.. Device class: 1.

Clearance details

Applicant: Ear Tech, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1988-06-15
Decision date: 1988-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bradenton, FL, 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

More clearances from Ear Tech, Inc.

view all

K932609 — EAR CURETTE1993-07-21

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