Sonotone Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Sonotone Intl., Inc. makes
Sonotone Intl., Inc. manufactures hearing aids designed for body-worn use and behind-the-ear applications, including models like the ST 1000 Body Aid and ST 54-0 BTE device.
These devices are classified as Class I under FDA regulations and are supported by 510(k) clearance records in the U.S. The company is based in the United States.
Catalogue
Sonotone Body Aid Model St 1000 Body Worn Ref K915517
Regimes: 510(k) Registry: 510(k)Sonotone Behind The Ear Model St 54-0 Ref K914897
Regimes: 510(k) Registry: 510(k)Sonotone Behind The Ear Model St 49 Ref K915518
Regimes: 510(k) Registry: 510(k)Sonotone Behind The Ear Model St 53A Ref K915519
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sonotone Intl., Inc. have in the registry?
The registry currently lists 4 devices for Sonotone Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sonotone Intl., Inc.'s devices?
Among its 4 most recently registered devices, Sonotone Intl., Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Sonotone Intl., Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sonotone Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sonotone Intl., Inc. in the registry?
The most recently registered devices listed for Sonotone Intl., Inc. include SONOTONE BODY AID MODEL ST 1000 BODY WORN, SONOTONE BEHIND THE EAR MODEL ST 54-0, SONOTONE BEHIND THE EAR MODEL ST 49 and SONOTONE BEHIND THE EAR MODEL ST 53A.