510(k) K161534 ยท BTY Calculator, Predicted Values, Pulmonary Function
EasyOne Pro Respiratory Analysis System
| Applicant | Ndd Medizintechnik AG, Zurich, CH |
| Decision | Substantially Equivalent, Feb 22, 2017 |
| Received | Jun 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161534
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2017 | NDDd Medical Technologies, Inc. EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1 Terminated |
BTY | None listed |
| Aug 15, 2017 | NDDd Medical Technologies, Inc. EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1 Terminated |
BTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.