TEA 设备
K号: K230526 · 2023-09-14
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决定日期2023-09-14
产品代码QHH
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
TEA Device is the device name listed in this FDA 510(k) record. The listed applicant is Transtimulation Research, Inc.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K230526. The device is classified under product code QHH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TEA Device?
TEA Device is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Transtimulation Research, Inc.. The 510(k) number is K230526.
When did TEA Device receive FDA 510(k) clearance?
TEA Device received FDA 510(k) clearance on 2023-09-14, under 510(k) number K230526.
Who is the listed applicant for TEA Device?
The FDA 510(k) record lists Transtimulation Research, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TEA Device?
The FDA product code for TEA Device is QHH.
相关临床试验
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列明Transtimulation Research, Inc.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：QHH）
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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