FDA 510(k)

LOUFOCON® 銀離子泡沫敷料，LOUFOCON® 銀離子抗菌泡沫敷料

K 號：K223359 · 2023-12-21

申請人Huizhou Foryou Medical Devices Co., Ltd.

決定日期2023-12-21

產品代碼FRO

決定相當於

器材摘要

LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam 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 2023-12-21 under 510(k) number K223359. 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® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing?

LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K223359.

When did LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing receive FDA 510(k) clearance?

LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing received FDA 510(k) clearance on 2023-12-21, under 510(k) number K223359.

Who is the listed applicant for LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam 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® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing?

The FDA product code for LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing is FRO. This falls under the Anesthesiology category.

其他以 Huizhou Foryou Medical Devices Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254256LOUFUCON® 黃金創傷組織 K250642LOUFOCON®皮膚及傷口清潔劑（噴霧、霧狀、壓嘴、瓶裝。）K240809LOUFOCON® 銀膠原蛋白敷料 K242856LUOFUCON®矽膠Ag+泡沫敷料（處方用）/ LUOFUCON®矽膠Ag+抗菌泡沫敷料（OTC用）(邊框型、邊框輕型、無邊框型和轉移型)K240485LUOFUCON® 銀膠凝纖維敷料（處方用），LUOFUCON® 銀抗菌膠凝纖維敷料（OTC用）K232796LOUFOCON® 膠原蛋白粒子（膠原蛋白傷口敷料）

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相關器械（代碼：FRO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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