Infinite Biomedical Technologies, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240884Glide (91000-GL-X)April 15, 2024
K182112Sense System with IBT ElectrodesOctober 5, 2018
K173571Element System with IBT ElectrodesMarch 21, 2018
K101386VIGILANT EEG MONITOR MODEL VIGILANT 2.0July 30, 2010
K091963VIGILANT EEG MONITOR, VIGILANT 2.0November 6, 2009
K072382MODEL I-2000 MONITORFebruary 15, 2008