精子對齊分離設備
K 號：K232980 · 2024-03-14
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決定日期2024-03-14
產品代碼MQK
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
SpermAlign Sperm Separation Device is the device name listed in this FDA 510(k) record. The listed applicant is Cytoswim, Ltd.. It received FDA 510(k) clearance on 2024-03-14 under 510(k) number K232980. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SpermAlign Sperm Separation Device?
SpermAlign Sperm Separation Device is a medical device that received FDA 510(k) clearance on 2024-03-14. The listed applicant is Cytoswim, Ltd.. The 510(k) number is K232980.
When did SpermAlign Sperm Separation Device receive FDA 510(k) clearance?
SpermAlign Sperm Separation Device received FDA 510(k) clearance on 2024-03-14, under 510(k) number K232980.
Who is the listed applicant for SpermAlign Sperm Separation Device?
The FDA 510(k) record lists Cytoswim, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SpermAlign Sperm Separation Device?
The FDA product code for SpermAlign Sperm Separation Device is MQK.
相關臨床試驗
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相關器械（代碼：MQK）
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。
K241626SperSort™ 精子分選晶片 (IPG02)Ipreg IncorporationK241454Minitro® 經濟化玻璃針 (MVT-VSN 系列包括 MVT-VSNR、MVT-VSNY、MVT-VSNB、MVT-VSNG、MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® 收穫器（1 mL）；SwimCount® 收穫器（3 mL）Motilitycount ApsK241341冷凍-GO 經濟化設備Fujifilm Irvine ScientificK240002G-Vitri™ 冷凍針Gimbo Medical Technology Shenzhen Co., Ltd.K233177Nest VT 液化設備Cook Incorporated
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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