FDA 510(k)

LensHooke CA1 精子分离装置，LensHooke CA0 精子分离装置

K号: K221810 · 2022-10-31

决定日期2022-10-31

产品代码MQK

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决定实质等同

器械摘要

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.

常见问题

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.

列明Bonraybio Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242830LensHooke X3 PRO 精子质量分析仪；LensHooke X3 PRO SE 精子质量分析仪 K242388LensHooke X12 PRO 精子分析系统 K202089LensHooke X1 PRO 精子质量分析仪，LensHooke X1 PRO SE 精子质量分析仪 K180343LensHooke X1 Pro 精子质量分析仪，LensHooke X1 精子质量分析仪

官方来源

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