FDA 510(k)

LT抗細菌藻鹼銀膠布

K 號：K192478 · 2020-06-17

申請人Zhejiang Longterm Medical Technology Co., Ltd.

決定日期2020-06-17

產品代碼FRO

決定相當於

器材摘要

LT Antibacterial Alginate with Silver Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K192478. 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 LT Antibacterial Alginate with Silver Dressing?

LT Antibacterial Alginate with Silver Dressing is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K192478.

When did LT Antibacterial Alginate with Silver Dressing receive FDA 510(k) clearance?

LT Antibacterial Alginate with Silver Dressing received FDA 510(k) clearance on 2020-06-17, under 510(k) number K192478.

Who is the listed applicant for LT Antibacterial Alginate with Silver Dressing?

FDA 510(k) 記錄將浙江長期醫療技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for LT Antibacterial Alginate with Silver Dressing?

The FDA product code for LT Antibacterial Alginate with Silver Dressing is FRO. This falls under the Anesthesiology category.

其他以 Zhejiang Longterm Medical Technology 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。

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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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