510(k) K121891 ยท CBK Ventilator, Continuous, Facility Use
NEWPORT AURA VENTILATOR
| Applicant | Newport Medical Instruments, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Nov 9, 2012 |
| Received | Jun 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121891
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.