The following data is part of a premarket notification filed by Infinite Biomedical Technologies, Llc with the FDA for Vigilant Eeg Monitor Model Vigilant 2.0.
| Device ID | K101386 |
| 510k Number | K101386 |
| Device Name: | VIGILANT EEG MONITOR MODEL VIGILANT 2.0 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | INFINITE BIOMEDICAL TECHNOLOGIES, LLC 3600 CLIPPER MILL ROAD SUITE 410 Baltimore, MD 21211 |
| Contact | Manan Hathi |
| Correspondent | Manan Hathi INFINITE BIOMEDICAL TECHNOLOGIES, LLC 3600 CLIPPER MILL ROAD SUITE 410 Baltimore, MD 21211 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-18 |
| Decision Date | 2010-07-30 |