510(k) K965079 ยท LEL Device, Sleep Assessment
SOMNITOR 32K SLEEP ACTIVITY MONITOR
| Applicant | Neurim Pharmaceuticals, Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Jul 10, 1997 |
| Received | Dec 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965079
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.