Laboratorios Biogalenic Sterile Water for Inhalation, USP

About This 510(k) Submission

K242717 is an FDA 510(k) clearance for the Laboratorios Biogalenic Sterile Water for Inhalation, USP, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Laboratorios Biogalenic S.A. DE C.V. (San Salvador, SV). The FDA issued a Cleared decision on January 30, 2025, 142 days after receiving the submission on September 10, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.