FDA 510(k)

無菌銀鹼鹼傷口敷料

K 號：K220673 · 2023-03-16

申請人Qingdao Bright Moon Biomedical Materials Co., Ltd.

決定日期2023-03-16

產品代碼FRO

決定相當於

器材摘要

Sterile Silver Alginate Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Bright Moon Biomedical Materials Co., Ltd.. It received FDA 510(k) clearance on 2023-03-16 under 510(k) number K220673. 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 Sterile Silver Alginate Wound Dressing?

Sterile Silver Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-03-16. The listed applicant is Qingdao Bright Moon Biomedical Materials Co., Ltd.. The 510(k) number is K220673.

When did Sterile Silver Alginate Wound Dressing receive FDA 510(k) clearance?

Sterile Silver Alginate Wound Dressing received FDA 510(k) clearance on 2023-03-16, under 510(k) number K220673.

Who is the listed applicant for Sterile Silver Alginate Wound Dressing?

The FDA 510(k) record lists Qingdao Bright Moon Biomedical Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Silver Alginate Wound Dressing?

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

其他以 Qingdao Bright Moon Biomedical Materials 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。

K252167強化銀膠膠維織敷料（OTC）超強化銀膠膠維織敷料（處方）

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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