FDA 510(k)

U by Kotex® Click® 非香型月經棉條

K 號：K223749 · 2023-01-06

決定日期2023-01-06

產品代碼HEB

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

U by Kotex® Click® Unscented Menstrual Tampons is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corporation. It received FDA 510(k) clearance on 2023-01-06 under 510(k) number K223749. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the U by Kotex® Click® Unscented Menstrual Tampons?

U by Kotex® Click® Unscented Menstrual Tampons is a medical device that received FDA 510(k) clearance on 2023-01-06. The listed applicant is Kimberly-Clark Corporation. The 510(k) number is K223749.

When did U by Kotex® Click® Unscented Menstrual Tampons receive FDA 510(k) clearance?

U by Kotex® Click® Unscented Menstrual Tampons received FDA 510(k) clearance on 2023-01-06, under 510(k) number K223749.

Who is the listed applicant for U by Kotex® Click® Unscented Menstrual Tampons?

The FDA 510(k) record lists Kimberly-Clark Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U by Kotex® Click® Unscented Menstrual Tampons?

The FDA product code for U by Kotex® Click® Unscented Menstrual Tampons is HEB.

其他以 Kimberly-Clark Corporation 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。

K231435KIMTECH™ Polaris™ Xtra乳膠無粉 Exam手套，已測試與化療藥物、阿片類芬太尼鹽酸、模擬胃酸及模擬胃酸中的芬太尼合用 K231021KIMTECH™ Polaris™ 硝基粉塵無檢查手套，已經通過與化療藥物、阿片類芬太尼鹽酸、模擬胃酸及模擬胃酸中的芬太尼的測試。K202416Kimtech Prizm 多層檢查手套，已經通過與化學治療藥物、鴉片類藥物芬太尼鹽酸、模擬胃酸以及胃酸中的芬太尼的測試，Kimtech Prizm Xtra 多層檢查手套，已經通過與化學治療藥物、鴉片類藥物芬太尼鹽酸、模擬胃酸以及胃酸中的芬太尼的測試 K200072KIMTECH 紫色硝基橡胶無粉檢查手套，經測試可與化學治療藥物、阿片類芬太尼、胃酸及胃酸中的芬太尼使用。K172118U by Kotex 非香型月經衛生棉棒

相關器械（代碼：HEB）

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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