# Qualitone

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 40 (1976–1996): 40 510(k) clearances
- Names in FDA's records: Qualitone (39); Qualitone, Inc. (1)
- Product codes: ESD (34), EWO (5), EXD (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K961827: IN-the-Ear (Jul 3, 1996)
- K955466: Dynameq-II Option (Feb 13, 1996)
- K955359: Cyber Iii Option UM, UC312, UC10, Ucic (Dec 19, 1995)
- K953884: Prophet (Oct 27, 1995)
- K941107: The Canal (C.I.C.) Aka/Hidden Ear (Aug 9, 1994)
- K935348: Odyssey Clinical Audiometer (Feb 9, 1994)
- K935289: Pro Fit-Cyber II Option (Dec 22, 1993)
- K923006: AS-90 (Sep 18, 1993)

Source page: https://510kreport.com/company/qualitone