Kedly, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Kedly, Inc. makes
Kedly, Inc. manufactures the Audioscreener OAE, a device for objective hearing screening using otoacoustic emissions (OAE), and the Audioscreener OAE + ABR, which combines OAE testing with auditory brainstem response (ABR) assessments. These tools are designed for early detection of hearing impairments in infants and young children.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the 510(k) clearance registry. The portfolio is regulated in the United States.
Catalogue
Audioscreener Oae Ref K000184
Regimes: 510(k) Registry: 510(k)Audioscreener Oae + Abr Ref K001058
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kedly, Inc. have in the registry?
The registry currently lists 2 devices for Kedly, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kedly, Inc.'s devices?
Among its 2 most recently registered devices, Kedly, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Kedly, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Kedly, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kedly, Inc. in the registry?
The most recently registered devices listed for Kedly, Inc. include AUDIOSCREENER OAE and AUDIOSCREENER OAE + ABR.