FDA 510(k)

Copper Foam Dressing (Prescription and OTC)

Número K: K231088 · 2024-01-11

Data da decisão2024-01-11

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Copper Foam Dressing (Prescription and OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K231088. 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 Copper Foam Dressing (Prescription and OTC)?

Copper Foam Dressing (Prescription and OTC) is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Roosin Medical Co., Ltd.. The 510(k) number is K231088.

When did Copper Foam Dressing (Prescription and OTC) receive FDA 510(k) clearance?

Copper Foam Dressing (Prescription and OTC) received FDA 510(k) clearance on 2024-01-11, under 510(k) number K231088.

Who is the listed applicant for Copper Foam Dressing (Prescription and OTC)?

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

What is the FDA product code for Copper Foam Dressing (Prescription and OTC)?

The FDA product code for Copper Foam Dressing (Prescription and OTC) is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Roosin Medical Co., Ltd. como candidato(a)

K253974Roosin Collagen Dressing K254034Roosin Collagen Powder K230190Polyver Silver Alginate Dressing (Prescription and OTC)K181478Roosin Xeroform Petrolatum Dressing

Dispositivos Relacionados (Código: FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Fonte oficial

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