K251419
- 510(k) number
- K251419
- Device name
- Laboratorios Biogalenic Sterile Water for Inhalation, USP
- Applicant
- Laboratorios Biogalenic S.A. DE C.V. SV
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2026-01-14
- Date received
- 2025-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K251419.pdf
Official FDA record: K251419
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.