FDA 510(k)

Laboratorios Biogalenic Sterile Water for Inhalation, USP

Número K: K251419 · 2026-01-14

RequerenteLaboratorios Biogalenic S.A. DE C.V.

Data da decisão2026-01-14

Código do produtoBTT

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Laboratorios Biogalenic Sterile Water for Inhalation, USP is the device name listed in this FDA 510(k) record. The listed applicant is Laboratorios Biogalenic S.A. DE C.V.. It received FDA 510(k) clearance on 2026-01-14 under 510(k) number K251419. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Laboratorios Biogalenic Sterile Water for Inhalation, USP?

Laboratorios Biogalenic Sterile Water for Inhalation, USP is a medical device that received FDA 510(k) clearance on 2026-01-14. The listed applicant is Laboratorios Biogalenic S.A. DE C.V.. The 510(k) number is K251419.

When did Laboratorios Biogalenic Sterile Water for Inhalation, USP receive FDA 510(k) clearance?

Laboratorios Biogalenic Sterile Water for Inhalation, USP received FDA 510(k) clearance on 2026-01-14, under 510(k) number K251419.

Who is the listed applicant for Laboratorios Biogalenic Sterile Water for Inhalation, USP?

The FDA 510(k) record lists Laboratorios Biogalenic S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laboratorios Biogalenic Sterile Water for Inhalation, USP?

The FDA product code for Laboratorios Biogalenic Sterile Water for Inhalation, USP is BTT.

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Outros registros que listam Laboratorios Biogalenic S.A. DE C.V. como candidato(a)

K243001Sterile Water USP and Sterile 0.9% Normal Saline USP K242717Laboratorios Biogalenic Sterile Water for Inhalation, USP

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Fonte oficial

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