FDA 510(k)

含PHMB的抗菌矽膠泡沫傷口敷料

K 號：K223310 · 2023-04-05

決定日期2023-04-05

產品代碼FRO

決定相當於

器材摘要

Antimicrobial Silicone PHMB Foam Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions Limited. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K223310. 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 Antimicrobial Silicone PHMB Foam Wound Dressing?

Antimicrobial Silicone PHMB Foam Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Advanced Medical Solutions Limited. The 510(k) number is K223310.

When did Antimicrobial Silicone PHMB Foam Wound Dressing receive FDA 510(k) clearance?

Antimicrobial Silicone PHMB Foam Wound Dressing received FDA 510(k) clearance on 2023-04-05, under 510(k) number K223310.

Who is the listed applicant for Antimicrobial Silicone PHMB Foam Wound Dressing?

The FDA 510(k) record lists Advanced Medical Solutions Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Antimicrobial Silicone PHMB Foam Wound Dressing?

The FDA product code for Antimicrobial Silicone PHMB Foam Wound Dressing is FRO. This falls under the Anesthesiology category.

其他以 Advanced Medical Solutions Limited 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。

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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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