510(k) K201082 ยท CBK Ventilator, Continuous, Facility Use
LTV2 Series Ventilators
| Applicant | Vyaire Medical, Inc., Mettawa IL, US |
| Decision | Substantially Equivalent, Nov 10, 2021 |
| Received | Apr 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201082
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.