ALLONUS Tech假肢
K号: K241616 · 2024-12-17
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决定日期2024-12-17
产品代码NHA
咨询委员会DE
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决定实质等同
器械摘要
ALLONUS Tech Prosthetics is the device name listed in this FDA 510(k) record. The listed applicant is Allonus Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K241616. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ALLONUS Tech Prosthetics?
ALLONUS Tech Prosthetics is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Allonus Tech Co., Ltd.. The 510(k) number is K241616.
When did ALLONUS Tech Prosthetics receive FDA 510(k) clearance?
ALLONUS Tech Prosthetics received FDA 510(k) clearance on 2024-12-17, under 510(k) number K241616.
Who is the listed applicant for ALLONUS Tech Prosthetics?
The FDA 510(k) record lists Allonus Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ALLONUS Tech Prosthetics?
The FDA product code for ALLONUS Tech Prosthetics is NHA.
相关临床试验
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相关器械（代码：NHA）
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
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