Aurora
K号: K251153 · 2025-06-12
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器械摘要
Aurora is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Israel. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251153. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aurora?
Aurora is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Ge Medical Systems Israel. The 510(k) number is K251153.
When did Aurora receive FDA 510(k) clearance?
Aurora received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251153.
Who is the listed applicant for Aurora?
The FDA 510(k) record lists Ge Medical Systems Israel as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aurora?
The FDA product code for Aurora is KPS.
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：KPS）
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。
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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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