510(k) K163127 ยท CBK Ventilator, Continuous, Facility Use
bellavista 1000
| Applicant | Imtmedical AG, Buchs Sg, CH |
| Decision | Substantially Equivalent, Jul 31, 2017 |
| Received | Nov 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2019 | Vyaire Medical bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air an Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.