AURICAL HIT— 510(k) K122028

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K122028 for AURICAL HIT, Substantially Equivalent on 2012-10-23. Applicant: Gn Otometrics. Device class: 2.

Clearance details

Applicant: Gn Otometrics
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 2012-07-10
Decision date: 2012-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETW

K113831 — PRIMUS HEARING INSTRUMENT TEST UNIT2012-04-19
K110286 — GN OTOMETRICS TYPE 1053 FREEFIT2011-04-28
K093006 — FONIX ,MODEL 80002009-12-30
K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)2007-06-05
K061104 — SPEECHLINK 100 TYPE 10532006-05-03

More clearances from Gn Otometrics

K161707 — Madsen Zodiac2016-09-01
K151504 — ICS Impulse2015-11-16
K132957 — MADSEN ACCUSCREEN TYPE 10772014-02-27
K122550 — ICS IMPULSE2013-02-01
K122067 — TYPE 1077 ACCUSCREEN2012-09-27

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