510(k) K122857 ยท CAF Nebulizer (Direct Patient Interface)
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
| Applicant | Pegasus Research Corp., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Nov 7, 2012 |
| Received | Sep 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122857
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.