Bionit Labs Srl

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)March 12, 2026
K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)January 2, 2025