冷凍機器選擇系統
K 號：K221086 · 2022-11-04
廣告
決定日期2022-11-04
產品代碼QUJ
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
CryoRobot Select System is the device name listed in this FDA 510(k) record. The listed applicant is Tmrw Life Sciences, Inc.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K221086. The device is classified under product code QUJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CryoRobot Select System?
CryoRobot Select System is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Tmrw Life Sciences, Inc.. The 510(k) number is K221086.
When did CryoRobot Select System receive FDA 510(k) clearance?
CryoRobot Select System received FDA 510(k) clearance on 2022-11-04, under 510(k) number K221086.
Who is the listed applicant for CryoRobot Select System?
The FDA 510(k) record lists Tmrw Life Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CryoRobot Select System?
The FDA product code for CryoRobot Select System is QUJ.
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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。
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