FDA 510(k)

生物加倫尼克實驗室靜脈注射用无菌水，USP

K 號：K242717 · 2025-01-30

決定日期2025-01-30

產品代碼BTT

諮詢委員會AN

決定相當於

器材摘要

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 2025-01-30 under 510(k) number K242717. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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 2025-01-30. The listed applicant is Laboratorios Biogalenic S.A. DE C.V.. The 510(k) number is K242717.

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 2025-01-30, under 510(k) number K242717.

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.

其他以 Laboratorios Biogalenic S.A. DE C.V. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251419生物加倫尼克實驗室靜脈注射用无菌水，USP K243001無菌注射用水 USP 及无菌 0.9% 正常鹽水 USP

相關器械（代碼：BTT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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