FDA 510(k)

無菌注射用水 USP 及无菌 0.9% 正常鹽水 USP

K 號：K243001 · 2025-03-06

決定日期2025-03-06

產品代碼FRO

決定相當於

器材摘要

Sterile Water USP and Sterile 0.9% Normal Saline 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 2025-03-06 under 510(k) number K243001. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Water USP and Sterile 0.9% Normal Saline USP?

Sterile Water USP and Sterile 0.9% Normal Saline USP is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Laboratorios Biogalenic S.A. DE C.V.. The 510(k) number is K243001.

When did Sterile Water USP and Sterile 0.9% Normal Saline USP receive FDA 510(k) clearance?

Sterile Water USP and Sterile 0.9% Normal Saline USP received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243001.

Who is the listed applicant for Sterile Water USP and Sterile 0.9% Normal Saline 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 Sterile Water USP and Sterile 0.9% Normal Saline USP?

The FDA product code for Sterile Water USP and Sterile 0.9% Normal Saline USP is FRO. This falls under the Anesthesiology category.

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

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相關器械（代碼：FRO）

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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