Company ยท US
Qualitone
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1996. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 1996 | K961827 | IN-THE-EAR Qualitone | ESD |
| Feb 13, 1996 | K955466 | DYNAMEQ-II OPTION Qualitone | ESD |
| Dec 19, 1995 | K955359 | CYBER III OPTION UM, UC312, UC10, UCIC Qualitone | ESD |
| Oct 27, 1995 | K953884 | PROPHET Qualitone | EWO |
| Aug 9, 1994 | K941107 | THE CANAL (C.I.C.) AKA/HIDDEN EAR Qualitone, Inc. | ESD |
| Feb 9, 1994 | K935348 | ODYSSEY CLINICAL AUDIOMETER Qualitone | EWO |
| Dec 22, 1993 | K935289 | PRO FIT-CYBER II OPTION Qualitone | ESD |
| Sep 18, 1993 | K923006 | AS-90 Qualitone | ESD |
| Feb 26, 1993 | K923007 | AT-2 Qualitone | EWO |
| Sep 10, 1992 | K923986 | CYBERNETIC OPTION (CYBER I) Qualitone | ESD |
| Aug 14, 1992 | K923013 | ACOUSTIC APPRAISE CD-3 Qualitone | EWO |
| Sep 23, 1991 | K914017 | UC312, ULTRA MINIATURE ITC HEARING AID Qualitone | ESD |
| Sep 18, 1991 | K913781 | QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID Qualitone | ESD |
| Sep 18, 1991 | K913771 | ELEGANCE - KED, BEHIND THE EAR HEARING AID Qualitone | ESD |
| Sep 18, 1991 | K913592 | QUALITONE 46PP-AGC-I Qualitone | ESD |
| Jun 17, 1991 | K912154 | QUALITONE MODEL 48 C-WR-BEHIND THE EAR Qualitone | ESD |
| Jun 17, 1991 | K912153 | QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR Qualitone | ESD |
| Apr 19, 1991 | K911504 | ULTRA & ULTRA LITE II, MODIFICATION Qualitone | ESD |
| Apr 19, 1991 | K911499 | ELEGANCE - DEO, MODIFICATION Qualitone | ESD |
| Apr 19, 1991 | K911498 | ADJUSTRETTE - DAO, MODIFICATION Qualitone | ESD |
| Apr 19, 1991 | K911497 | CUSTOM PERSONAL EAR - CPE Qualitone | ESD |
| Dec 17, 1990 | K904731 | QUALITONE ITE GENESIS Qualitone | ESD |
| Dec 7, 1990 | K904730 | QUALITONE ULTRA CANAL GENESIS Qualitone | ESD |
| Oct 31, 1990 | K904544 | ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID Qualitone | EWO |
| Aug 3, 1989 | K892338 | BEHIND-THE-EAR HEARING AID MODEL 48 AGCI Qualitone | ESD |
| May 19, 1989 | K892336 | BEHIND-THE-EAR HEARING AID MODEL 48 PP PC Qualitone | ESD |
| May 10, 1989 | K892337 | BEHIND-THE-EAR HEARING AID MODEL 46 PP PC Qualitone | ESD |
| Jun 4, 1985 | K851970 | QUALITONE STOCK CANAL AID Qualitone | ESD |
| Dec 13, 1984 | K843789 | ULTRA & ULTRA MINATURE Qualitone | ESD |
| Apr 3, 1984 | K840165 | CANAL AID Qualitone | ESD |
| Oct 2, 1981 | K812578 | ELEGANCE Qualitone | ESD |
| Mar 31, 1981 | K810577 | POWER SONIC Qualitone | ESD |
| Jan 26, 1979 | K790095 | MODULE PERSONAL EAR (DELUXE) Qualitone | ESD |
| Jan 26, 1979 | K790094 | MODULE PERSONAL EAR (COMPRESSION) Qualitone | ESD |
| Jan 26, 1979 | K790093 | MODULE PERSONAL EAR (SUPER) Qualitone | ESD |
| Feb 17, 1978 | K780241 | COMPRESSION MULTISONIC Qualitone | ESD |
| Jun 24, 1977 | K771069 | MULTISONIC (SUPER) CODE TSM Qualitone | ESD |
| Jun 22, 1977 | K771029 | MULTISONIC (DELUXE) CODE TDM Qualitone | ESD |
| Feb 28, 1977 | K770251 | SUPER X ADJUSTRETTE Qualitone | EXD |
| Nov 3, 1976 | K760887 | COMPRESSION ADJUSTRETTE Qualitone | ESD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||