Lumos 3DX
K号: K223780 · 2023-07-06
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申请人3Dio
决定日期2023-07-06
产品代码EHD
咨询委员会DE
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决定实质等同
器械摘要
Lumos 3DX is the device name listed in this FDA 510(k) record. The listed applicant is 3Dio. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K223780. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lumos 3DX?
Lumos 3DX is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is 3Dio. The 510(k) number is K223780.
When did Lumos 3DX receive FDA 510(k) clearance?
Lumos 3DX received FDA 510(k) clearance on 2023-07-06, under 510(k) number K223780.
Who is the listed applicant for Lumos 3DX?
The FDA 510(k) record lists 3Dio as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lumos 3DX?
The FDA product code for Lumos 3DX is EHD.
相关临床试验
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相关器械（代码：EHD）
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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