FDA 510(k)

LensHooke CA1 精子分離設備，LensHooke CA0 精子分離設備

K 號：K221810 · 2022-10-31

決定日期2022-10-31

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

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device is the device name listed in this FDA 510(k) record. The listed applicant is Bonraybio Co., Ltd.. It received FDA 510(k) clearance on 2022-10-31 under 510(k) number K221810. 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 LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device?

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device is a medical device that received FDA 510(k) clearance on 2022-10-31. The listed applicant is Bonraybio Co., Ltd.. The 510(k) number is K221810.

When did LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device receive FDA 510(k) clearance?

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device received FDA 510(k) clearance on 2022-10-31, under 510(k) number K221810.

Who is the listed applicant for LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device?

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

What is the FDA product code for LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device?

The FDA product code for LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device is MQK.

其他以 Bonraybio Co., Ltd. 為申請人之記錄

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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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