ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID— 510(k) K922392

Name: FDA 510(k) clearance K922392
Creator: U.S. Food and Drug Administration
Published: 1992-07-10

Substantially Equivalent

A-1 Hearing Aid Lab

FDA 510(k) clearance K922392 for ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID, Substantially Equivalent on 1992-07-10. Applicant: A-1 Hearing Aid Lab. Device class: 1.

Clearance details

Applicant: A-1 Hearing Aid Lab
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1992-05-20
Decision date: 1992-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gulfport, MS, 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.