FDA 510(k)

iMedium單步；iMedium單步搭配HSA；iMedium單步搭配rHA

K 號：K193522 · 2020-08-25

決定日期2020-08-25

產品代碼MQL

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

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K193522. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Kitazato Corporation. The 510(k) number is K193522.

When did iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA receive FDA 510(k) clearance?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA received FDA 510(k) clearance on 2020-08-25, under 510(k) number K193522.

Who is the listed applicant for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

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

What is the FDA product code for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

The FDA product code for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is MQL.

其他以 Kitazato Corporation 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。

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相關器械（代碼：MQL）

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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