VIGILANT EEG MONITOR MODEL VIGILANT 2.0
Device Facts
| Record ID | K101386 |
|---|---|
| Device Name | VIGILANT EEG MONITOR MODEL VIGILANT 2.0 |
| Applicant | Infinite Biomedical Technologies, LLC |
| Product Code | GWQ · Neurology |
| Decision Date | Jul 30, 2010 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
