FDA 510(k)

Laboratorios Biogalenic Sterile Water for Inhalation, USP

K-번호: K251419 · 2026-01-14

결정일2026-01-14

제품 코드BTT

자문 위원회AN

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Laboratorios Biogalenic S.A. DE C.V.를 신청인으로 등재한 기타 기록

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

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