FDA 510(k)

Tosama 生態基礎應用管月經衛生棉

K 號：K172504 · 2018-02-09

決定日期2018-02-09

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

Tosama Biobased Applicator Tube Menstrual Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Tosama, D.O.O.. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172504. 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 Tosama Biobased Applicator Tube Menstrual Tampon?

Tosama Biobased Applicator Tube Menstrual Tampon is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Tosama, D.O.O.. The 510(k) number is K172504.

When did Tosama Biobased Applicator Tube Menstrual Tampon receive FDA 510(k) clearance?

Tosama Biobased Applicator Tube Menstrual Tampon received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172504.

Who is the listed applicant for Tosama Biobased Applicator Tube Menstrual Tampon?

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

What is the FDA product code for Tosama Biobased Applicator Tube Menstrual Tampon?

The FDA product code for Tosama Biobased Applicator Tube Menstrual Tampon is HEB.

其他以 Tosama, D.O.O. 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。

K232060TOSAMA 可重用施用器

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。