FDA 510(k)

LUOFUCON Extra 銀藻酸鹽敷料, LUOFUCON Extra 抗菌藻酸鹽敷料

K 號：K172554 · 2018-05-01

申請人Huizhou Foryou Medical Devices Co., Ltd.

決定日期2018-05-01

產品代碼FRO

決定相當於

器材摘要

LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate 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 2018-05-01 under 510(k) number K172554. 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 Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing?

LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing is a medical device that received FDA 510(k) clearance on 2018-05-01. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K172554.

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

LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing received FDA 510(k) clearance on 2018-05-01, under 510(k) number K172554.

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

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