FDA 510(k)

矽膠PHMB泡沫傷口敷料

K 號：K190819 · 2019-07-25

決定日期2019-07-25

產品代碼FRO

決定相當於

器材摘要

Silicone PHMB Foam Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K190819. 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 Silicone PHMB Foam Wound Dressing?

Silicone PHMB Foam Wound Dressing is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K190819.

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

Silicone PHMB Foam Wound Dressing received FDA 510(k) clearance on 2019-07-25, under 510(k) number K190819.

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

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

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

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

其他以 Advanced Medical Solutions, 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。

K213473含PHMB的抗菌膠凝纖維敷料 K210974高性能銀離子抗菌膠凝纖維 K183645銀色高性能敷料 K180634外科銀色術後敷料 K181197PHMB泡沫傷口敷料 K163062PHMB 抗菌泡沫傷口敷料

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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。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

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