FDA 510(k)

铜泡沫敷料（处方药和非处方药）

K号: K231088 · 2024-01-11

决定日期2024-01-11

产品代码FRO

决定实质等同

器械摘要

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.

常见问题

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.

列明Roosin Medical Co., 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。

K253974Roosin 胶原蛋白敷料 K254034Roosin 胶原粉 K230190Polyver 硅银藻酸盐敷料（处方药和非处方药）K181478Roosin Xeroform 凡士林敷料

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。