510(k) K961817 ยท LEL Device, Sleep Assessment
B SMART MODEL 1
| Applicant | Koven Technology, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jul 23, 1997 |
| Received | May 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961817
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.