HEARING AID (ALL-IN-EAR)— 510(k) K862545

Substantially Equivalent

Vibrasonic, Inc.

FDA 510(k) clearance K862545 for HEARING AID (ALL-IN-EAR), Substantially Equivalent on 1986-07-16. Applicant: Vibrasonic, Inc.. Device class: 1.

Clearance details

Applicant: Vibrasonic, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1986-07-03
Decision date: 1986-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Missoula, MT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ESD

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.