510(k) K912817 ยท LEL Device, Sleep Assessment
SOMNIMIC (R)
| Applicant | Somnitec, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Jul 26, 1991 |
| Received | May 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912817
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.