Biointellisense Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2616-2024Class IIBioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoringJuly 19, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K241101BioButton SystemSeptember 26, 2024
K191614BioSticker SystemDecember 18, 2019