510(k) K091963 ยท OLT Non-Normalizing Quantitative Electroencephalograph Software
VIGILANT EEG MONITOR, VIGILANT 2.0
| Applicant | Infinite Biomedical Technologies, LLC, Baltimore MD, US |
| Decision | Substantially Equivalent, Nov 6, 2009 |
| Received | Jul 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091963
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.