FDA 510(k)

撕裂修復液皮膚保護劑

K 號：K241916 · 2024-09-27

決定日期2024-09-27

產品代碼KMF

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

TearRepair Liquid Skin Protectant is the device name listed in this FDA 510(k) record. The listed applicant is Optmed, Inc.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241916. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TearRepair Liquid Skin Protectant?

TearRepair Liquid Skin Protectant is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Optmed, Inc.. The 510(k) number is K241916.

When did TearRepair Liquid Skin Protectant receive FDA 510(k) clearance?

TearRepair Liquid Skin Protectant received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241916.

Who is the listed applicant for TearRepair Liquid Skin Protectant?

The FDA 510(k) record lists Optmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TearRepair Liquid Skin Protectant?

The FDA product code for TearRepair Liquid Skin Protectant is KMF.

其他以 Optmed, Inc. 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。

K243990BondEase 2 開放性皮膚膠粘劑

相關器械（代碼：KMF）

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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