510(k) K250312 · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
| Applicant | Medline Industries, LP, Northfiled IL, US |
| Decision | Substantially Equivalent, Jul 2, 2025 |
| Received | Feb 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250312
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.