Phoenix ICON，Phoenix ICON GO
K号: K223575 · 2023-09-06
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决定日期2023-09-06
产品代码HKI
咨询委员会OP
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决定实质等同
器械摘要
Phoenix ICON, Phoenix ICON GO is the device name listed in this FDA 510(k) record. The listed applicant is Neolight, LLC. It received FDA 510(k) clearance on 2023-09-06 under 510(k) number K223575. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Phoenix ICON, Phoenix ICON GO?
Phoenix ICON, Phoenix ICON GO is a medical device that received FDA 510(k) clearance on 2023-09-06. The listed applicant is Neolight, LLC. The 510(k) number is K223575.
When did Phoenix ICON, Phoenix ICON GO receive FDA 510(k) clearance?
Phoenix ICON, Phoenix ICON GO received FDA 510(k) clearance on 2023-09-06, under 510(k) number K223575.
Who is the listed applicant for Phoenix ICON, Phoenix ICON GO?
The FDA 510(k) record lists Neolight, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Phoenix ICON, Phoenix ICON GO?
The FDA product code for Phoenix ICON, Phoenix ICON GO is HKI.
相关临床试验
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列明Neolight, LLC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：HKI）
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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