Medical Device Manufacturer · US , Eden Prairie , MN

Gn Danavox, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1986
10
Total
10
Cleared
0
Denied

FDA 510(k) Regulatory Record - Gn Danavox, Inc. Ear, Nose, Throat ✕

10 devices
1-10 of 10
Cleared Jun 17, 1997
AUDALLION III HEARING SYSTEM
K971031 · ESD
Ear, Nose, Throat · 88d
Cleared Jun 17, 1997
DANAVOX MODELS 163/162 BTE
K971032 · ESD
Ear, Nose, Throat · 88d
Cleared Nov 15, 1994
DANAVOX MODEL CIC
K942331 · ESD
Ear, Nose, Throat · 183d
Cleared Nov 03, 1992
DFS GENIUS BTE
K924185 · ESD
Ear, Nose, Throat · 75d
Cleared Jan 28, 1991
133 SERIES BTE
K905679 · ESD
Ear, Nose, Throat · 40d
Cleared Jan 28, 1991
143 SERIES BTE
K905692 · ESD
Ear, Nose, Throat · 40d
Cleared Aug 09, 1990
CAS (COMPUTERIZED ANALYZER SYSTEM)
K896996 · ETW
Ear, Nose, Throat · 241d
Cleared Apr 30, 1990
DISCRETION, IN THE CANAL HEARING INSTRUMENT
K896995 · ESD
Ear, Nose, Throat · 140d
Cleared May 10, 1989
CERUMEN FILTER
K891594 · ESD
Ear, Nose, Throat · 51d
Cleared Nov 07, 1986
CUSTOM IN-THE-EAR
K863975 · ESD
Ear, Nose, Throat · 24d
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