FDA 510(k)

每秒都重要-子宮內膜氣囊填塞術（“ESM-UBT”）

K 號：K191264 · 2019-10-30

決定日期2019-10-30

產品代碼OQY

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

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is the device name listed in this FDA 510(k) record. The listed applicant is Ujenzi Charitable Trust. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K191264. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Ujenzi Charitable Trust. The 510(k) number is K191264.

When did Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) receive FDA 510(k) clearance?

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) received FDA 510(k) clearance on 2019-10-30, under 510(k) number K191264.

Who is the listed applicant for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

The FDA 510(k) record lists Ujenzi Charitable Trust as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

The FDA product code for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is OQY.

相關器械（代碼：OQY）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OQY）

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