510(k) K111514 ยท LEL Device, Sleep Assessment
SBV2, MULTICHARGER MODEL MC10V2
| Applicant | Sleep Performance D.B.A. Fatigue Science, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 16, 2011 |
| Received | Jun 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111514
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.