510(k) K182618 ยท MNR Ventilatory Effort Recorder
SleepImage System
| Applicant | Mycardio, LLC Dba Sleepimage., Denver CO, US |
| Decision | Substantially Equivalent, Aug 14, 2019 |
| Received | Sep 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182618
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.