510(k) K163696 ยท MNR Ventilatory Effort Recorder
SleepImage System
| Applicant | Mycardio, LLC Dba Sleepimage., Broomfield CO, US |
| Decision | Substantially Equivalent, Oct 13, 2017 |
| Received | Dec 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163696
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.