Qualitone
Mchenry, IL, US
Qualitone appears in FDA device records in Mchenry, IL. FDA records list 40 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 40
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 40 510(k) clearances for Qualitone between 1976 and 1996. The busiest year on record is 1991, with 10. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 3 |
| 1978 | 1 |
| 1979 | 3 |
| 1981 | 2 |
| 1984 | 2 |
| 1985 | 1 |
| 1989 | 3 |
| 1990 | 3 |
| 1991 | 10 |
| 1992 | 2 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961827 | IN-THE-EAR | ESD | Substantially Equivalent | |
| K955466 | DYNAMEQ-II OPTION | ESD | Substantially Equivalent | |
| K955359 | CYBER III OPTION UM, UC312, UC10, UCIC | ESD | Substantially Equivalent | |
| K953884 | PROPHET | EWO | Substantially Equivalent | |
| K941107 | THE CANAL (C.I.C.) AKA/HIDDEN EAR | ESD | Substantially Equivalent | |
| K935348 | ODYSSEY CLINICAL AUDIOMETER | EWO | Substantially Equivalent | |
| K935289 | PRO FIT-CYBER II OPTION | ESD | Substantially Equivalent | |
| K923006 | AS-90 | ESD | Substantially Equivalent | |
| K923007 | AT-2 | EWO | Substantially Equivalent | |
| K923986 | CYBERNETIC OPTION (CYBER I) | ESD | Substantially Equivalent | |
| K923013 | ACOUSTIC APPRAISE CD-3 | EWO | Substantially Equivalent | |
| K914017 | UC312, ULTRA MINIATURE ITC HEARING AID | ESD | Substantially Equivalent | |
| K913781 | QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID | ESD | Substantially Equivalent | |
| K913771 | ELEGANCE - KED, BEHIND THE EAR HEARING AID | ESD | Substantially Equivalent | |
| K913592 | QUALITONE 46PP-AGC-I | ESD | Substantially Equivalent | |
| K912154 | QUALITONE MODEL 48 C-WR-BEHIND THE EAR | ESD | Substantially Equivalent | |
| K912153 | QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR | ESD | Substantially Equivalent | |
| K911504 | ULTRA & ULTRA LITE II, MODIFICATION | ESD | Substantially Equivalent | |
| K911499 | ELEGANCE - DEO, MODIFICATION | ESD | Substantially Equivalent | |
| K911498 | ADJUSTRETTE - DAO, MODIFICATION | ESD | Substantially Equivalent | |
| K911497 | CUSTOM PERSONAL EAR - CPE | ESD | Substantially Equivalent | |
| K904731 | QUALITONE ITE GENESIS | ESD | Substantially Equivalent | |
| K904730 | QUALITONE ULTRA CANAL GENESIS | ESD | Substantially Equivalent | |
| K904544 | ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID | EWO | Substantially Equivalent | |
| K892338 | BEHIND-THE-EAR HEARING AID MODEL 48 AGCI | ESD | Substantially Equivalent | |
| K892336 | BEHIND-THE-EAR HEARING AID MODEL 48 PP PC | ESD | Substantially Equivalent | |
| K892337 | BEHIND-THE-EAR HEARING AID MODEL 46 PP PC | ESD | Substantially Equivalent | |
| K851970 | QUALITONE STOCK CANAL AID | ESD | Substantially Equivalent | |
| K843789 | ULTRA & ULTRA MINATURE | ESD | Substantially Equivalent | |
| K840165 | CANAL AID | ESD | Substantially Equivalent | |
| K812578 | ELEGANCE | ESD | Substantially Equivalent | |
| K810577 | POWER SONIC | ESD | Substantially Equivalent | |
| K790095 | MODULE PERSONAL EAR (DELUXE) | ESD | Substantially Equivalent | |
| K790094 | MODULE PERSONAL EAR (COMPRESSION) | ESD | Substantially Equivalent | |
| K790093 | MODULE PERSONAL EAR (SUPER) | ESD | Substantially Equivalent | |
| K780241 | COMPRESSION MULTISONIC | ESD | Substantially Equivalent | |
| K771069 | MULTISONIC (SUPER) CODE TSM | ESD | Substantially Equivalent | |
| K771029 | MULTISONIC (DELUXE) CODE TDM | ESD | Substantially Equivalent | |
| K770251 | SUPER X ADJUSTRETTE | EXD | Substantially Equivalent | |
| K760887 | COMPRESSION ADJUSTRETTE | ESD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain