Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Qualitone with 40 510(k) clearances. The most recent is a 510(k) clearance dated Jul 3, 1996: IN-THE-EAR.
| Date | Record | Source |
|---|---|---|
| Jul 3, 1996 | IN-THE-EARK961827 · ESD | 510(k) clearances |
| Feb 13, 1996 | DYNAMEQ-II OPTIONK955466 · ESD | 510(k) clearances |
| Dec 19, 1995 | CYBER III OPTION UM, UC312, UC10, UCICK955359 · ESD | 510(k) clearances |
| Oct 27, 1995 | PROPHETK953884 · EWO | 510(k) clearances |
| Aug 9, 1994 | THE CANAL (C.I.C.) AKA/HIDDEN EARK941107 · ESD | 510(k) clearances |
| Feb 9, 1994 | ODYSSEY CLINICAL AUDIOMETERK935348 · EWO | 510(k) clearances |
| Dec 22, 1993 | PRO FIT-CYBER II OPTIONK935289 · ESD | 510(k) clearances |
| Sep 18, 1993 | AS-90K923006 · ESD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
