Medical Device Manufacturer · ZA , Pretoria

Hearx SA (Pty) , Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hearx SA (Pty) , Ltd. Ear, Nose, Throat ✕
2 devices
1-2 of 2
Cleared Oct 27, 2023
hearOAE
K231545 · EWO
Ear, Nose, Throat · 150d
Cleared Mar 14, 2023
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
K223137 · QUH
Ear, Nose, Throat · 161d
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