Medical Device Manufacturer · US , Roanoke , VA

General Hearing Instruments, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1985
5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - General Hearing Instruments, Inc. Ear, Nose, Throat ✕

5 devices
1-5 of 5
Cleared Jun 30, 2006
TRANQUIL TRI-BTE
K061459 · KLW
Ear, Nose, Throat · 35d
Cleared Mar 06, 1998
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
K974751 · ESD
Ear, Nose, Throat · 77d
Cleared Jun 13, 1997
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
K971399 · ESD
Ear, Nose, Throat · 59d
Cleared Jul 20, 1994
AURIS CIC
K943144 · ESD
Ear, Nose, Throat · 21d
Cleared Mar 21, 1985
IN-TH-EAR HEARING AID
K850123 · ESD
Ear, Nose, Throat · 66d
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