Gn Otometrics A/S is one of 42 FDA 510(k) medical device manufacturers from Denmark in the dataset, ranked by real submission volume.
Gn Otometrics A/S - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Gn Otometrics A/S has 6 FDA 510(k) cleared medical devices. Based in Taastrup, DK.
Historical record: 6 cleared submissions from 2004 to 2015. Primary specialty: Ear, Nose, Throat.
Browse the FDA 510(k) cleared devices submitted by Gn Otometrics A/S Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Gn Otometrics A/S
6 devices
Cleared
Oct 23, 2015
ICS CHARTR EP 200 WITH VEMP
Neurology
303d
Cleared
Apr 28, 2011
GN OTOMETRICS TYPE 1053 FREEFIT
Ear, Nose, Throat
87d
Cleared
Feb 20, 2009
ICS CHARTR EP 200
Neurology
95d
Cleared
Jul 11, 2006
FOCUS VNG/ENG TYPE 1068
Neurology
15d
Cleared
May 03, 2006
SPEECHLINK 100 TYPE 1053
Ear, Nose, Throat
13d
Cleared
Mar 31, 2004
OTOFLEX 100 TYE 1012
Ear, Nose, Throat
132d