FDA 510(k)

LOUFOCON 銀膠凝纖維敷料，LOUFOCON 銀抗菌膠凝纖維敷料

K 號：K210718 · 2022-03-23

申請人Huizhou Foryou Medical Devices Co., Ltd.

決定日期2022-03-23

產品代碼FRO

決定相當於

器材摘要

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K210718. 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.

常見問題

What is the LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing?

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K210718.

When did LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing receive FDA 510(k) clearance?

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing received FDA 510(k) clearance on 2022-03-23, under 510(k) number K210718.

Who is the listed applicant for LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing?

FDA 510(k) 記錄將惠州富友醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing?

The FDA product code for LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing is FRO. This falls under the Anesthesiology category.