Ion 3D
K号: K241416 · 2024-06-17
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器械摘要
Ion 3D is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2024-06-17 under 510(k) number K241416. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.
常见问题
What is the Ion 3D?
Ion 3D is a medical device that received FDA 510(k) clearance on 2024-06-17. The listed applicant is SurGenTec, LLC. The 510(k) number is K241416.
When did Ion 3D receive FDA 510(k) clearance?
Ion 3D received FDA 510(k) clearance on 2024-06-17, under 510(k) number K241416.
Who is the listed applicant for Ion 3D?
FDA 510(k)记录中列出SurGenTec, LLC为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Ion 3D?
The FDA product code for Ion 3D is MRW.
列明SurGenTec, 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：MRW）
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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