FDA 510(k)

COHITECH 有機棉應用棒棉棒輕量版

K 號：K182813 · 2019-03-15

決定日期2019-03-15

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 ORGANIC COTTON APPLICATOR TAMPONS LIGHT 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 2019-03-15 under 510(k) number K182813. 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 ORGANIC COTTON APPLICATOR TAMPONS LIGHT?

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Cotton High Tech S.L.. The 510(k) number is K182813.

When did COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT receive FDA 510(k) clearance?

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT received FDA 510(k) clearance on 2019-03-15, under 510(k) number K182813.

Who is the listed applicant for COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT?

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 ORGANIC COTTON APPLICATOR TAMPONS LIGHT?

The FDA product code for COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT is HEB.

其他以 Cotton High Tech S.L. 為申請人之記錄

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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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