TuxDeluxe（尺寸1 6100B，尺寸2 6101B）
K号: K232552 · 2023-10-20
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决定日期2023-10-20
产品代码MUH
咨询委员会DE
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器械摘要
TuxDeluxe (Size 1 6100B, Size 2 6101B) is the device name listed in this FDA 510(k) record. The listed applicant is Tuxedo Imaging, LLC. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K232552. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TuxDeluxe (Size 1 6100B, Size 2 6101B)?
TuxDeluxe (Size 1 6100B, Size 2 6101B) is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Tuxedo Imaging, LLC. The 510(k) number is K232552.
When did TuxDeluxe (Size 1 6100B, Size 2 6101B) receive FDA 510(k) clearance?
TuxDeluxe (Size 1 6100B, Size 2 6101B) received FDA 510(k) clearance on 2023-10-20, under 510(k) number K232552.
Who is the listed applicant for TuxDeluxe (Size 1 6100B, Size 2 6101B)?
The FDA 510(k) record lists Tuxedo Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TuxDeluxe (Size 1 6100B, Size 2 6101B)?
The FDA product code for TuxDeluxe (Size 1 6100B, Size 2 6101B) is MUH.
相关临床试验
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相关器械（代码：MUH）
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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