Seaman Pro/Seaman
K号: K252228 · 2026-04-09
广告
决定日期2026-04-09
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
Seaman Pro/Seaman is the device name listed in this FDA 510(k) record. The listed applicant is Checkcells, Inc.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K252228. 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 Seaman Pro/Seaman?
Seaman Pro/Seaman is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Checkcells, Inc.. The 510(k) number is K252228.
When did Seaman Pro/Seaman receive FDA 510(k) clearance?
Seaman Pro/Seaman received FDA 510(k) clearance on 2026-04-09, under 510(k) number K252228.
Who is the listed applicant for Seaman Pro/Seaman?
The FDA 510(k) record lists Checkcells, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Seaman Pro/Seaman?
The FDA product code for Seaman Pro/Seaman 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。
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。
K242830LensHooke X3 PRO 精子质量分析仪；LensHooke X3 PRO SE 精子质量分析仪Bonraybio Co., Ltd.K242388LensHooke X12 PRO 精子分析系统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