510(k) K112041 ยท CAF Nebulizer (Direct Patient Interface)
KOO SMALL VOLUME NEBULIZER (SVN)
| Applicant | Koo (Shanghai) Industries Co., Ltd., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Dec 22, 2011 |
| Received | Jul 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112041
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.