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FDA 510(k)

Field Shield 创面敷料

K号: K212521 · 2024-07-18

决定日期2024-07-18
产品代码FRO
决定实质等同

器械摘要

Field Shield Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Kericure, Inc.. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K212521. 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 Field Shield Wound Dressing?

Field Shield Wound Dressing is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Kericure, Inc.. The 510(k) number is K212521.

When did Field Shield Wound Dressing receive FDA 510(k) clearance?

Field Shield Wound Dressing received FDA 510(k) clearance on 2024-07-18, under 510(k) number K212521.

Who is the listed applicant for Field Shield Wound Dressing?

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

What is the FDA product code for Field Shield Wound Dressing?

The FDA product code for Field Shield Wound Dressing is FRO. This falls under the Anesthesiology category.

相关临床试验

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。

相关器械(代码:FRO)

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。

官方来源

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