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FDA 510(k)

抗菌繃帶

K 號:K200821 · 2020-10-19

決定日期2020-10-19
產品代碼FRO
決定相當於

器材摘要

anti-bacterial bandage is the device name listed in this FDA 510(k) record. The listed applicant is Planet (Suzhou) Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K200821. 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 anti-bacterial bandage?

anti-bacterial bandage is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Planet (Suzhou) Medical Products Co., Ltd.. The 510(k) number is K200821.

When did anti-bacterial bandage receive FDA 510(k) clearance?

anti-bacterial bandage received FDA 510(k) clearance on 2020-10-19, under 510(k) number K200821.

Who is the listed applicant for anti-bacterial bandage?

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

What is the FDA product code for anti-bacterial bandage?

The FDA product code for anti-bacterial bandage is FRO. This falls under the Anesthesiology category.

相關臨床試驗

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。

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。

官方來源

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