Qualitone - FDA 510(k) Cleared Devices

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