510(k) K081551 ยท OMA Amplitude-Integrated Electroencephalograph
TWIN NEUROTRAC-III
| Applicant | Astro-Med, Inc., West Warwick RI, US |
| Decision | Substantially Equivalent, Dec 24, 2008 |
| Received | Jun 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081551
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.