510(k) K150810 ยท BZC Calculator, Pulmonary Function Data
Vyntus / SentrySuite Product Line
| Applicant | Carefusion Germany 234 GmbH, Hoechberg, DE |
| Decision | Substantially Equivalent, Aug 14, 2015 |
| Received | Mar 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150810
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2024 | Vyaire Medical, Inc. Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter fo Open, Classified |
BZC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.