510(k) K181912 ยท BTY Calculator, Predicted Values, Pulmonary Function
Ascent Cardiorespiratory Diagnostic Software
| Applicant | Medical Graphics Corporation, St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 12, 2019 |
| Received | Jul 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181912
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.