Medical Device Manufacturer · DK , Ballerup

GN Hearing A/S - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2018
4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - GN Hearing A/S Ear, Nose, Throat ✕

4 devices
1-4 of 4
Cleared Jan 19, 2022
Jabra Enhance Plus
K213424 · QDD
Ear, Nose, Throat · 90d
Cleared Feb 20, 2020
Tinnitus Sound Generator Module
K193303 · KLW
Ear, Nose, Throat · 83d
Cleared Nov 30, 2018
Tinnitus Sound Generator Module
K180495 · KLW
Ear, Nose, Throat · 277d
Cleared Jul 13, 2018
Tinnitus Sound Generator Module
K181586 · KLW
Ear, Nose, Throat · 28d
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