Medical Device Manufacturer · US , Eden Prairie , MN

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

10 submissions · 10 cleared · Since 1986

Recent clearances: AUDALLION III HEARING SYSTEM, DANAVOX MODELS 163/162 BTE

Total

Cleared

Denied

Gn Danavox, Inc. has 10 FDA 510(k) cleared ear, nose, throat devices. Based in Eden Prairie, US.

Historical record: 10 cleared submissions from 1986 to 1997.

Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.

Gn Danavox, Inc. is one of 15029 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Gn Danavox, Inc.

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

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

FDA 510(k) Regulatory Record - Gn Danavox, Inc.

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