510(k) K100380 ยท CAF Nebulizer (Direct Patient Interface)
ALTERA NEBULIZER SYSTEM, MODEL 678G1002
| Applicant | Pari Respiratory Equipment, Inc., Midlothian VA, US |
| Decision | Substantially Equivalent, Feb 22, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100380
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.