Embryo Predict
K号: K250781 · 2026-05-15
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申请人Alife Health
决定日期2026-05-15
产品代码PBH
咨询委员会OB
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决定实质等同
器械摘要
Embryo Predict is the device name listed in this FDA 510(k) record. The listed applicant is Alife Health. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K250781. The device is classified under product code PBH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Embryo Predict?
Embryo Predict is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Alife Health. The 510(k) number is K250781.
When did Embryo Predict receive FDA 510(k) clearance?
Embryo Predict received FDA 510(k) clearance on 2026-05-15, under 510(k) number K250781.
Who is the listed applicant for Embryo Predict?
The FDA 510(k) record lists Alife Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Embryo Predict?
The FDA product code for Embryo Predict is PBH.
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:PBH)
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。
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。
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