510(k) K050425 ยท OLV Standard Polysomnograph With Electroencephalograph
AURA-PSG
| Applicant | Astro-Med, Inc., West Warwick RI, US |
| Decision | Substantially Equivalent, Oct 20, 2005 |
| Received | Feb 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050425
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.