FDA 510(k)

Roosin Xeroform 凡士林敷料

K号: K181478 · 2019-09-13

决定日期2019-09-13

产品代码FRO

决定实质等同

器械摘要

Roosin Xeroform Petrolatum Dressing 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 2019-09-13 under 510(k) number K181478. 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 Roosin Xeroform Petrolatum Dressing?

Roosin Xeroform Petrolatum Dressing is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Roosin Medical Co., Ltd.. The 510(k) number is K181478.

When did Roosin Xeroform Petrolatum Dressing receive FDA 510(k) clearance?

Roosin Xeroform Petrolatum Dressing received FDA 510(k) clearance on 2019-09-13, under 510(k) number K181478.

Who is the listed applicant for Roosin Xeroform Petrolatum Dressing?

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 Roosin Xeroform Petrolatum Dressing?

The FDA product code for Roosin Xeroform Petrolatum Dressing 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。

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