FDA 510(k)

无菌注射用水 USP 和无菌 0.9% 生理盐水 USP

K号: K243001 · 2025-03-06

决定日期2025-03-06

产品代码FRO

决定实质等同

器械摘要

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.

常见问题

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.

列明Laboratorios Biogalenic S.A. DE C.V.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251419Biogalenic 生物实验室无菌吸入用水，USP K242717Biogalenic 生物实验室无菌吸入用水，USP

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。