510(k) K101386 ยท GWQ Full-Montage Standard Electroencephalograph
VIGILANT EEG MONITOR MODEL VIGILANT 2.0
| Applicant | Infinite Biomedical Technologies, LLC, Baltimore MD, US |
| Decision | Substantially Equivalent, Jul 30, 2010 |
| Received | May 18, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101386
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.