510(k) K875134 ยท CAF Nebulizer (Direct Patient Interface)
OMRON ULTRASONIC NEBULIZER NE-U06
| Applicant | Nidek, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Dec 5, 1988 |
| Received | Dec 15, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875134
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.