Medical Device Manufacturer · DK , Taastrup

Gn Otometrics A/S - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2004
6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Gn Otometrics A/S Neurology ✕

3 devices
1-3 of 3
Cleared Oct 23, 2015
ICS CHARTR EP 200 WITH VEMP
K143670 · GWJ
Neurology · 303d
Cleared Feb 20, 2009
ICS CHARTR EP 200
K083399 · GWJ
Neurology · 95d
Cleared Jul 11, 2006
FOCUS VNG/ENG TYPE 1068
K061791 · GWN
Neurology · 15d
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