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FDA 510(k)

Sterile Water USP and Sterile 0.9% Normal Saline USP

K-Number: K243001 · 2025-03-06

ApplicantLaboratorios Biogalenic S.A. DE C.V.
Decision Date2025-03-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Sterile Water USP and Sterile 0.9% Normal Saline USP is a medical device manufactured by Laboratorios Biogalenic S.A. DE C.V.. It received FDA 510(k) clearance on 2025-03-06 under approval 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.

Frequently Asked Questions

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. It is manufactured by Laboratorios Biogalenic S.A. DE C.V.. The 510(k) number is K243001.

When was Sterile Water USP and Sterile 0.9% Normal Saline USP approved by the FDA?

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

What company makes Sterile Water USP and Sterile 0.9% Normal Saline USP?

Sterile Water USP and Sterile 0.9% Normal Saline USP is manufactured by Laboratorios Biogalenic S.A. DE C.V..

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.

Related Clinical Trials

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Other Devices by Laboratorios Biogalenic S.A. DE C.V.

K242717Laboratorios Biogalenic Sterile Water for Inhalation, USP K251419Laboratorios Biogalenic Sterile Water for Inhalation, USP

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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