Medical Device Manufacturer · IT , Soleto

Bionit Labs Srl - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bionit Labs Srl Neurology ✕

1 devices

1-1 of 1

Cleared Jan 02, 2025

Wave Electrode (AE02-60)

Neurology · 149d