AIR CONDUCTION HEARING AID: IKON PP— 510(k) K936106

Name: FDA 510(k) clearance K936106
Creator: U.S. Food and Drug Administration
Published: 1994-03-21

Substantially Equivalent

Unitron Industries, Inc.

FDA 510(k) clearance K936106 for AIR CONDUCTION HEARING AID: IKON PP, Substantially Equivalent on 1994-03-21. Applicant: Unitron Industries, Inc.. Device class: 1.

Clearance details

Applicant: Unitron Industries, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1993-12-22
Decision date: 1994-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, 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 Unitron Industries, Inc.

view all

K974338 — UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)1997-12-12
K974339 — UNITRON MODEL SOUND F/XD PROGRAMMABLE1997-12-12
K974340 — UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE1997-12-12
K970692 — UNITRON MODEL SOUND F/X CIC1997-05-08
K970519 — UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)1997-04-24

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