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447
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386
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345
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Manufacturers
US
Gn Otometrics
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
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 01, 2016
Madsen Zodiac
K161707
·
ETY
Ear, Nose, Throat
·
72d
Cleared
Oct 23, 2012
AURICAL HIT
K122028
·
ETW
Ear, Nose, Throat
·
105d
Cleared
Jul 14, 2008
GN OTOMETRICS INSERT EARPHONES
K081234
·
EWO
Ear, Nose, Throat
·
74d
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8
Neurology
5
Ear, Nose, Throat
3