Medical Device Manufacturer · US , Mchenry , IL

Qualitone - FDA 510(k) Cleared Devices

39 submissions · 39 cleared · Since 1976

Total

Cleared

Denied

Qualitone has 39 FDA 510(k) cleared ear, nose, throat devices. Based in Mchenry, US.

Historical record: 39 cleared submissions from 1976 to 1996.

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.

Qualitone is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Qualitone

39 devices

1-12 of 39

Cleared Jul 03, 1996

IN-THE-EAR

K961827 · ESD

Ear, Nose, Throat · 51d

Cleared Feb 13, 1996

DYNAMEQ-II OPTION

K955466 · ESD

Ear, Nose, Throat · 75d

Cleared Dec 19, 1995

CYBER III OPTION UM, UC312, UC10, UCIC

K955359 · ESD

Ear, Nose, Throat · 27d

Cleared Oct 27, 1995

PROPHET

K953884 · EWO

Ear, Nose, Throat · 71d

Cleared Feb 09, 1994

ODYSSEY CLINICAL AUDIOMETER

K935348 · EWO

Ear, Nose, Throat · 96d

Cleared Dec 22, 1993

PRO FIT-CYBER II OPTION

K935289 · ESD

Ear, Nose, Throat · 49d

Cleared Sep 18, 1993

AS-90

K923006 · ESD

Ear, Nose, Throat · 453d

Cleared Feb 26, 1993

AT-2

K923007 · EWO

Ear, Nose, Throat · 249d

Cleared Sep 10, 1992

CYBERNETIC OPTION (CYBER I)

K923986 · ESD

Ear, Nose, Throat · 34d

Cleared Aug 14, 1992

ACOUSTIC APPRAISE CD-3

K923013 · EWO

Ear, Nose, Throat · 53d

Cleared Sep 23, 1991

UC312, ULTRA MINIATURE ITC HEARING AID

K914017 · ESD

Ear, Nose, Throat · 14d

Cleared Sep 18, 1991

QUALITONE 46PP-AGC-I

K913592 · ESD

Ear, Nose, Throat · 37d

Looking for a specific device from Qualitone? Search by device name or K-number.

Search all Qualitone devices

Qualitone - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Qualitone

Filters