FDA 510(k)

PHMB 識別傷口敷料

K 號：K221532 · 2023-01-30

決定日期2023-01-30

產品代碼FRO

決定相當於

器材摘要

PHMB Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-01-30 under 510(k) number K221532. 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 PHMB Wound Dressing?

PHMB Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-01-30. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K221532.

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

PHMB Wound Dressing received FDA 510(k) clearance on 2023-01-30, under 510(k) number K221532.

Who is the listed applicant for PHMB Wound Dressing?

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

What is the FDA product code for PHMB Wound Dressing?

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

其他以 Winner Medical 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。

K252001膠原蛋白傷口敷料 K250082程序口罩/外科口罩/臉部口罩 K231057抗菌膠膠布傷口敷料 K231564皮膚與傷口清潔劑 K231152膠原蛋白傷口敷料 K221311抗菌繃帶

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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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