BEHIND THE EAR HEARING AID MODEL BERNAFON T-82— 510(k) K851547

Name: FDA 510(k) clearance K851547
Creator: U.S. Food and Drug Administration
Published: 1985-05-29

Substantially Equivalent

Bernafon, Inc.

FDA 510(k) clearance K851547 for BEHIND THE EAR HEARING AID MODEL BERNAFON T-82, Substantially Equivalent on 1985-05-29. Applicant: Bernafon, Inc.. Device class: 1.

Clearance details

Applicant: Bernafon, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1985-04-16
Decision date: 1985-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountainside, NJ, 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 Bernafon, Inc.

view all

K880349 — MODEL 759 CUSTOM IN-THE-EAR HEARING AID1988-03-07
K874589 — BERNAFON COLIBRI, C-2H HEARING AIDS1987-12-04
K864823 — BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C11987-01-06
K864180 — INTEGRA, CUSTOM IN-THE-EAR HEARING AID1986-11-05
K860759 — CHARISMA HEARING AID1986-04-11

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