Qualitone

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
40
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K961827IN-THE-EARJuly 3, 1996
K955466DYNAMEQ-II OPTIONFebruary 13, 1996
K955359CYBER III OPTION UM, UC312, UC10, UCICDecember 19, 1995
K953884PROPHETOctober 27, 1995
K941107THE CANAL (C.I.C.) AKA/HIDDEN EARAugust 9, 1994
K935348ODYSSEY CLINICAL AUDIOMETERFebruary 9, 1994
K935289PRO FIT-CYBER II OPTIONDecember 22, 1993
K923006AS-90September 18, 1993
K923007AT-2February 26, 1993
K923986CYBERNETIC OPTION (CYBER I)September 10, 1992
K923013ACOUSTIC APPRAISE CD-3August 14, 1992
K914017UC312, ULTRA MINIATURE ITC HEARING AIDSeptember 23, 1991
K913771ELEGANCE - KED, BEHIND THE EAR HEARING AIDSeptember 18, 1991
K913781QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AIDSeptember 18, 1991
K913592QUALITONE 46PP-AGC-ISeptember 18, 1991
K912153QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EARJune 17, 1991
K912154QUALITONE MODEL 48 C-WR-BEHIND THE EARJune 17, 1991
K911504ULTRA & ULTRA LITE II, MODIFICATIONApril 19, 1991
K911498ADJUSTRETTE - DAO, MODIFICATIONApril 19, 1991
K911499ELEGANCE - DEO, MODIFICATIONApril 19, 1991