Qualitone
Medical device manufacturer in Minneapolis, MN.
40510(k) clearances
0PMA approvals
0recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K961827 | In-The-EarESD · Traditional | 07/03/1996SE |
| K955466 | Dynameq-Ii OptionESD · Traditional | 02/13/1996SE |
| K955359 | Cyber III Option Um, UC312, UC10, UcicESD · Traditional | 12/19/1995SE |
| K953884 | ProphetEWO · Traditional | 10/27/1995SE |
| K941107 | The Canal (C.I.C.) Aka/Hidden EarESD · Traditional | 08/09/1994SE |
| K935348 | Odyssey Clinical AudiometerEWO · Traditional | 02/09/1994SE |
| K935289 | Pro Fit-Cyber II OptionESD · Traditional | 12/22/1993SE |
| K923006 | AS-90ESD · Traditional | 09/18/1993SE |
| K923007 | AT-2EWO · Traditional | 02/26/1993SE |
| K923986 | Cybernetic Option (Cyber I)ESD · Traditional | 09/10/1992SE |
| K923013 | Acoustic Appraise CD-3EWO · Traditional | 08/14/1992SE |
| K914017 | UC312, Ultra Miniature Itc Hearing AidESD · Traditional | 09/23/1991SE |
| K913781 | Qualitone 48PP-AGC-I, Behind the Ear Hearing AidESD · Traditional | 09/18/1991SE |
| K913771 | Elegance - Ked, Behind the Ear Hearing AidESD · Traditional | 09/18/1991SE |
| K913592 | Qualitone 46PP-AGC-IESD · Traditional | 09/18/1991SE |
| K912154 | Qualitone Model 48 C-Wr-Behind the EarESD · Traditional | 06/17/1991SE |
| K912153 | Quiltone Model 48 Pp-Agc-I-D-Behind the EarESD · Traditional | 06/17/1991SE |
| K911504 | Ultra & Ultra Lite II, ModificationESD · Traditional | 04/19/1991SE |
| K911499 | Elegance - Deo, ModificationESD · Traditional | 04/19/1991SE |
| K911498 | Adjustrette - Dao, ModificationESD · Traditional | 04/19/1991SE |
| K911497 | Custom Personal Ear - CpeESD · Traditional | 04/19/1991SE |
| K904731 | Qualitone Ite GenesisESD · Traditional | 12/17/1990SE |
| K904730 | Qualitone Ultra Canal GenesisESD · Traditional | 12/07/1990SE |
| K904544 | Acoustic Appraiser CD-2 Audiometer/Master Hear.AidEWO · Traditional | 10/31/1990SE |
| K892338 | Behind-The-Ear Hearing Aid Model 48 AgciESD · Traditional | 08/03/1989SE |
| K892336 | Behind-The-Ear Hearing Aid Model 48 PP PCESD · Traditional | 05/19/1989SE |
| K892337 | Behind-The-Ear Hearing Aid Model 46 PP PCESD · Traditional | 05/10/1989SE |
| K851970 | Qualitone Stock Canal AidESD · Traditional | 06/04/1985SE |
| K843789 | Ultra & Ultra MinatureESD · Traditional | 12/13/1984SE |
| K840165 | Canal AidESD · Traditional | 04/03/1984SE |
| K812578 | EleganceESD · Traditional | 10/02/1981SE |
| K810577 | Power SonicESD · Traditional | 03/31/1981SE |
| K790095 | Module Personal Ear (Deluxe)ESD · Traditional | 01/26/1979SE |
| K790094 | Module Personal Ear (Compression)ESD · Traditional | 01/26/1979SE |
| K790093 | Module Personal Ear (Super)ESD · Traditional | 01/26/1979SE |
| K780241 | Compression MultisonicESD · Traditional | 02/17/1978SE |
| K771069 | Multisonic (Super) Code TSMESD · Traditional | 06/24/1977SE |
| K771029 | Multisonic (Deluxe) Code TDMESD · Traditional | 06/22/1977SE |
| K770251 | Super X AdjustretteEXD · Traditional | 02/28/1977SE |
| K760887 | Compression AdjustretteESD · Traditional | 11/03/1976SE |