FDA 510(k)

Silver High Performance Dressing

Número K: K183645 · 2019-05-29

RequerenteAdvanced Medical Solutions, Ltd.

Data da decisão2019-05-29

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Silver High Performance Dressing 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 2019-05-29 under 510(k) number K183645. 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 Silver High Performance Dressing?

Silver High Performance Dressing is a medical device that received FDA 510(k) clearance on 2019-05-29. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K183645.

When did Silver High Performance Dressing receive FDA 510(k) clearance?

Silver High Performance Dressing received FDA 510(k) clearance on 2019-05-29, under 510(k) number K183645.

Who is the listed applicant for Silver High Performance Dressing?

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 Silver High Performance Dressing?

The FDA product code for Silver High Performance Dressing is FRO. This falls under the Anesthesiology category.

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Fonte oficial

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