FDA 510(k)

Antimicrobiano Gelling Fiber Dressing com PHMB

Número K: K213473 · 2023-10-26

RequerenteAdvanced Medical Solutions, Ltd.

Data da decisão2023-10-26

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Antimicrobial Gelling Fiber Dressing with PHMB is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K213473. 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.

Perguntas frequentes

What is the Antimicrobial Gelling Fiber Dressing with PHMB?

Antimicrobial Gelling Fiber Dressing with PHMB is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K213473.

When did Antimicrobial Gelling Fiber Dressing with PHMB receive FDA 510(k) clearance?

Antimicrobial Gelling Fiber Dressing with PHMB received FDA 510(k) clearance on 2023-10-26, under 510(k) number K213473.

Who is the listed applicant for Antimicrobial Gelling Fiber Dressing with PHMB?

The FDA 510(k) record lists Advanced Medical Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Antimicrobial Gelling Fiber Dressing with PHMB?

The FDA product code for Antimicrobial Gelling Fiber Dressing with PHMB is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Advanced Medical Solutions, Ltd. como candidato(a)

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Fonte oficial

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