510(k) K042655 ยท CAF Nebulizer (Direct Patient Interface)
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
| Applicant | Respironics New Jersey, Inc., Cedar Grove NJ, US |
| Decision | Substantially Equivalent, Oct 13, 2004 |
| Received | Sep 28, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042655
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.