FDA 510(k)

高科棉鎖棉條，可重用推管

K 號：K220238 · 2022-02-25

決定日期2022-02-25

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

Cohitech Cottonlock Tampons with Reusable Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Cotton High Tech S.L.. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K220238. 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 Cohitech Cottonlock Tampons with Reusable Applicator?

Cohitech Cottonlock Tampons with Reusable Applicator is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Cotton High Tech S.L.. The 510(k) number is K220238.

When did Cohitech Cottonlock Tampons with Reusable Applicator receive FDA 510(k) clearance?

Cohitech Cottonlock Tampons with Reusable Applicator received FDA 510(k) clearance on 2022-02-25, under 510(k) number K220238.

Who is the listed applicant for Cohitech Cottonlock Tampons with Reusable Applicator?

The FDA 510(k) record lists Cotton High Tech S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cohitech Cottonlock Tampons with Reusable Applicator?

The FDA product code for Cohitech Cottonlock Tampons with Reusable Applicator is HEB.

其他以 Cotton High Tech S.L. 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。

K252939COHITECH 有機棉緊湊式膠囊棒針 K211775Cohitech 有機棉非應用器棉鎖衛生棉棒 K212479Cohitech 可重用衛生棉棒施用器 K182813COHITECH 有機棉應用棒棉棒輕量版

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。

K252005Livi 裝置Liviwell, Inc.K253719無香月經長型置入器衛生棉條；無香月經紙盒置入器衛生棉條；無香月經數位衛生棉條Unibeauty (Hubei) Technology Co., Ltd.K252939COHITECH 有機棉緊湊式膠囊棒針Cotton High Tech S.L.K252613無香月經三件式推入式衛生棉棒Unibeauty (Hubei) Technology Co., Ltd.K251033無香月經長型針筒式衛生棉棒；無香月經精巧針筒式衛生棉棒；無香月經紙盒針筒式衛生棉棒；無香月經數位衛生棉棒Unibeauty (Hubei) Technology Co., Ltd.K242105SABA 月經棉棒Essity Higiene Y Salud Mexico. S.A. DE C.V.

官方來源

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