510(k) K103635 ยท CAF Nebulizer (Direct Patient Interface)
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
| Applicant | Aerogen, Ltd., Galway, IE |
| Decision | Substantially Equivalent, May 13, 2011 |
| Received | Dec 13, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103635
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.