FDA 510(k)

無香月經棉塞

K 號：K190218 · 2019-05-09

申請人Qingdao Youjia Hygiene Technology Co., Ltd.

決定日期2019-05-09

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

Unscented Menstrual Tampon is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Youjia Hygiene Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-09 under 510(k) number K190218. 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 Unscented Menstrual Tampon?

Unscented Menstrual Tampon is a medical device that received FDA 510(k) clearance on 2019-05-09. The listed applicant is Qingdao Youjia Hygiene Technology Co., Ltd.. The 510(k) number is K190218.

When did Unscented Menstrual Tampon receive FDA 510(k) clearance?

Unscented Menstrual Tampon received FDA 510(k) clearance on 2019-05-09, under 510(k) number K190218.

Who is the listed applicant for Unscented Menstrual Tampon?

The FDA 510(k) record lists Qingdao Youjia Hygiene Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unscented Menstrual Tampon?

The FDA product code for Unscented Menstrual Tampon is HEB.

其他以 Qingdao Youjia Hygiene Technology Co., Ltd. 為申請人之記錄

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K192557有家無香衛生棉棒，配塑料推管

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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