510(k) K012437 ยท MNR Ventilatory Effort Recorder
DEVILBISS SLEEP RECORDER MODEL # RM60
| Applicant | Sunrise Medical Hhg, Inc., Somerset PA, US |
| Decision | Substantially Equivalent, Jul 16, 2002 |
| Received | Jul 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012437
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.