DynaFlex 清晰托槽与按钮
K号: K230225 · 2023-06-05
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申请人Dyna Flex
决定日期2023-06-05
产品代码NJM
咨询委员会DE
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决定实质等同
器械摘要
DynaFlex Clear Brackets & Buttons is the device name listed in this FDA 510(k) record. The listed applicant is Dyna Flex. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K230225. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DynaFlex Clear Brackets & Buttons?
DynaFlex Clear Brackets & Buttons is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Dyna Flex. The 510(k) number is K230225.
When did DynaFlex Clear Brackets & Buttons receive FDA 510(k) clearance?
DynaFlex Clear Brackets & Buttons received FDA 510(k) clearance on 2023-06-05, under 510(k) number K230225.
Who is the listed applicant for DynaFlex Clear Brackets & Buttons?
The FDA 510(k) record lists Dyna Flex as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DynaFlex Clear Brackets & Buttons?
The FDA product code for DynaFlex Clear Brackets & Buttons is NJM.
相关临床试验
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列明Dyna Flex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：NJM）
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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