K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT— 510(k) K954038

Name: FDA 510(k) clearance K954038
Creator: U.S. Food and Drug Administration
Published: 1995-09-18

Substantially Equivalent

Argosy Electronics

FDA 510(k) clearance K954038 for K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT, Substantially Equivalent on 1995-09-18. Applicant: Argosy Electronics. Device class: 1.

Clearance details

Applicant: Argosy Electronics
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1995-08-28
Decision date: 1995-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, 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 Argosy Electronics

view all

K974242 — ARGOSY PROGRAMMABLE ONQUE1998-01-20
K971699 — ARGOSY DYNAMEQ1997-07-03
K961729 — ARGOSY PROGRAMMABLE1996-05-29
K952450 — WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL1995-07-06
K952451 — CLASS D LINEAR WITH ACTIVE TONE CONTROL1995-07-06

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