510(k) K003499 ยท LEL Device, Sleep Assessment
REMVIEW SLEEP RECORDER, MODEL 320
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Feb 9, 2001 |
| Received | Nov 13, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K003499
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.