510(k) K181524 ยท BZC Calculator, Pulmonary Function Data
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
| Applicant | Vyaire Medical, Inc., Hoechber, DE |
| Decision | Substantially Equivalent, Nov 30, 2018 |
| Received | Jun 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181524
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.