Medical Device Manufacturer · IL , Gan Yoshiya

Tuned , Ltd.

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied

Tuned , Ltd. — FDA 510(k) Submissions

Tuned , Ltd. has submitted 2 FDA 510(k) premarket notifications since 2023, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Self-fitting Air-conduction Hearing Aid, Over The Counter, Air-conduction Hearing Aid Software . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
Filters
Filter by Specialty
All2 Ear, Nose, Throat 2