510(k) K162785 ยท CAF Nebulizer (Direct Patient Interface)
Velox Nebulizer System
| Applicant | Pari Respiratory Equipment, Inc., Midlothian VA, US |
| Decision | Substantially Equivalent, Apr 14, 2017 |
| Received | Oct 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162785
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.