Medical Device Manufacturer · US , Schaumburg , IL

Gn Otometrics - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2008
8
Total
8
Cleared
0
Denied

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

5 devices
1-5 of 5
Cleared Nov 16, 2015
ICS Impulse
K151504 · GWN
Neurology · 165d
Cleared Feb 27, 2014
MADSEN ACCUSCREEN TYPE 1077
K132957 · GWJ
Neurology · 160d
Cleared Feb 01, 2013
ICS IMPULSE
K122550 · GWN
Neurology · 164d
Cleared Sep 27, 2012
TYPE 1077 ACCUSCREEN
K122067 · GWJ
Neurology · 73d
Cleared Sep 03, 2009
ICS CHARTR EP 200
K092373 · GWJ
Neurology · 29d
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