510(k) K133105 ยท CAF Nebulizer (Direct Patient Interface)
BREEZE NEBULIZER (NBR-10X)
| Applicant | Digio2 International Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Jun 24, 2014 |
| Received | Sep 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133105
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.