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Qualitone

FDA 510(k) & PMA Approved Devices — 39 products

Total Devices39

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K961827	IN-THE-EAR	ESD	1996-07-03	View
510(k)	K955466	DYNAMEQ-II OPTION	ESD	1996-02-13	View
510(k)	K955359	CYBER III OPTION UM, UC312, UC10, UCIC	ESD	1995-12-19	View
510(k)	K953884	PROPHET	EWO	1995-10-27	View
510(k)	K935348	ODYSSEY CLINICAL AUDIOMETER	EWO	1994-02-09	View
510(k)	K935289	PRO FIT-CYBER II OPTION	ESD	1993-12-22	View
510(k)	K923006	AS-90	ESD	1993-09-18	View
510(k)	K923007	AT-2	EWO	1993-02-26	View
510(k)	K923986	CYBERNETIC OPTION (CYBER I)	ESD	1992-09-10	View
510(k)	K923013	ACOUSTIC APPRAISE CD-3	EWO	1992-08-14	View
510(k)	K914017	UC312, ULTRA MINIATURE ITC HEARING AID	ESD	1991-09-23	View
510(k)	K913771	ELEGANCE - KED, BEHIND THE EAR HEARING AID	ESD	1991-09-18	View
510(k)	K913781	QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID	ESD	1991-09-18	View
510(k)	K913592	QUALITONE 46PP-AGC-I	ESD	1991-09-18	View
510(k)	K912154	QUALITONE MODEL 48 C-WR-BEHIND THE EAR	ESD	1991-06-17	View
510(k)	K912153	QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR	ESD	1991-06-17	View
510(k)	K911498	ADJUSTRETTE - DAO, MODIFICATION	ESD	1991-04-19	View
510(k)	K911499	ELEGANCE - DEO, MODIFICATION	ESD	1991-04-19	View
510(k)	K911497	CUSTOM PERSONAL EAR - CPE	ESD	1991-04-19	View
510(k)	K911504	ULTRA & ULTRA LITE II, MODIFICATION	ESD	1991-04-19	View

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