510(k) K251419 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Laboratorios Biogalenic Sterile Water for Inhalation, USP
| Applicant | Laboratorios Biogalenic S.A. DE C.V., San Salvador, SV |
| Decision | Substantially Equivalent, Jan 14, 2026 |
| Received | May 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251419
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.