Gn Otometrics is one of 4765 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Gn Otometrics - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
Gn Otometrics has 8 FDA 510(k) cleared medical devices. Based in Schaumburg, US.
Historical record: 8 cleared submissions from 2008 to 2016. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Gn Otometrics Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Gn Otometrics
8 devices
Cleared
Sep 01, 2016
Madsen Zodiac
Ear, Nose, Throat
72d
Cleared
Nov 16, 2015
ICS Impulse
Neurology
165d
Cleared
Feb 27, 2014
MADSEN ACCUSCREEN TYPE 1077
Neurology
160d
Cleared
Feb 01, 2013
ICS IMPULSE
Neurology
164d
Cleared
Oct 23, 2012
AURICAL HIT
Ear, Nose, Throat
105d
Cleared
Sep 27, 2012
TYPE 1077 ACCUSCREEN
Neurology
73d
Cleared
Sep 03, 2009
ICS CHARTR EP 200
Neurology
29d
Cleared
Jul 14, 2008
GN OTOMETRICS INSERT EARPHONES
Ear, Nose, Throat
74d