Azurion R3.1
K号: K254186 · 2026-01-16
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器械摘要
Azurion R3.1 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems B.V.. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K254186. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Azurion R3.1?
Azurion R3.1 is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Philips Medical Systems B.V.. The 510(k) number is K254186.
When did Azurion R3.1 receive FDA 510(k) clearance?
Azurion R3.1 received FDA 510(k) clearance on 2026-01-16, under 510(k) number K254186.
Who is the listed applicant for Azurion R3.1?
The FDA 510(k) record lists Philips Medical Systems B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Azurion R3.1?
The FDA product code for Azurion R3.1 is OWB.
相关临床试验
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列明Philips Medical Systems B.V.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：OWB）
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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