FDA 510(k)

MiraChlor Antimicrobial Wound Solution

Numéro K : K252023 · 2026-03-25

Date de décision2026-03-25

Code produitFRO

DécisionSubstantially Equivalent

Résumé du dispositif

MiraChlor Antimicrobial Wound Solution is the device name listed in this FDA 510(k) record. The listed applicant is Letus Corporation. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K252023. 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.

Questions fréquentes

What is the MiraChlor Antimicrobial Wound Solution?

MiraChlor Antimicrobial Wound Solution is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Letus Corporation. The 510(k) number is K252023.

When did MiraChlor Antimicrobial Wound Solution receive FDA 510(k) clearance?

MiraChlor Antimicrobial Wound Solution received FDA 510(k) clearance on 2026-03-25, under 510(k) number K252023.

Who is the listed applicant for MiraChlor Antimicrobial Wound Solution?

The FDA 510(k) record lists Letus Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiraChlor Antimicrobial Wound Solution?

The FDA product code for MiraChlor Antimicrobial Wound Solution is FRO. This falls under the Anesthesiology category.

Essais cliniques associés

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Dispositifs connexes (Code : FRO)

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Source officielle

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