510(k) K123614 ยท CAF Nebulizer (Direct Patient Interface)
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
| Applicant | Trudell Medical Intl., London, CA |
| Decision | Substantially Equivalent, Mar 11, 2013 |
| Received | Nov 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123614
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.