FDA 510(k)

高性能银敷料

K号: K183645 · 2019-05-29

决定日期2019-05-29

产品代码FRO

决定实质等同

器械摘要

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.

常见问题

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.

列明Advanced Medical Solutions, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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