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FDA 510(k)

Tegaderm 預後透明抗菌敷料

K 號:K251866 · 2025-10-10

決定日期2025-10-10
產品代碼FRO
決定相當於

器材摘要

Tegaderm Post-Op Transparent Antimicrobial Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Solventum US, LLC. It received FDA 510(k) clearance on 2025-10-10 under 510(k) number K251866. 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 Tegaderm Post-Op Transparent Antimicrobial Dressing?

Tegaderm Post-Op Transparent Antimicrobial Dressing is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Solventum US, LLC. The 510(k) number is K251866.

When did Tegaderm Post-Op Transparent Antimicrobial Dressing receive FDA 510(k) clearance?

Tegaderm Post-Op Transparent Antimicrobial Dressing received FDA 510(k) clearance on 2025-10-10, under 510(k) number K251866.

Who is the listed applicant for Tegaderm Post-Op Transparent Antimicrobial Dressing?

FDA 510(k) 記錄將 Solventum US, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Tegaderm Post-Op Transparent Antimicrobial Dressing?

The FDA product code for Tegaderm Post-Op Transparent Antimicrobial Dressing 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。

其他以 Solventum US, LLC 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。

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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