510(k) K183364 ยท CBK Ventilator, Continuous, Facility Use
Bellavista
| Applicant | Imtmedical AG, Buchs Sg, CH |
| Decision | Substantially Equivalent, Sep 13, 2019 |
| Received | Dec 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2023 | Vyaire Medical bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator Completed |
CBK | None listed |
| Jun 15, 2023 | Vyaire Medical bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator Completed |
CBK | None listed |
| Feb 16, 2022 | Vyaire Medical bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130.
The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adu Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.