LensHooke X12 PRO 精子分析系统
K号: K242388 · 2025-05-09
广告
决定日期2025-05-09
产品代码POV
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
LensHooke X12 PRO Semen Analysis System 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 2025-05-09 under 510(k) number K242388. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LensHooke X12 PRO Semen Analysis System?
LensHooke X12 PRO Semen Analysis System is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Bonraybio Co., Ltd.. The 510(k) number is K242388.
When did LensHooke X12 PRO Semen Analysis System receive FDA 510(k) clearance?
LensHooke X12 PRO Semen Analysis System received FDA 510(k) clearance on 2025-05-09, under 510(k) number K242388.
Who is the listed applicant for LensHooke X12 PRO Semen Analysis System?
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 X12 PRO Semen Analysis System?
The FDA product code for LensHooke X12 PRO Semen Analysis System is POV.
相关临床试验
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。
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。
相关器械（代码：POV）
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。
K252228Seaman Pro/SeamanCheckcells, Inc.K242830LensHooke X3 PRO 精子质量分析仪；LensHooke X3 PRO SE 精子质量分析仪Bonraybio Co., Ltd.K243114SQA-iOw 精子质量分析仪Medical Electronic Systems , Ltd.K241628YO家用精子检测Medical Electronic Systems , Ltd.K220828SQA-iO 精子质量分析仪Medical Electronic Systems , Ltd.K202089LensHooke X1 PRO 精子质量分析仪，LensHooke X1 PRO SE 精子质量分析仪Bonraybio Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告