Sober Self-Test
K号: K250609 · 2025-09-15
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决定日期2025-09-15
产品代码DIC
咨询委员会TX
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决定实质等同
器械摘要
Sober Self-Test is the device name listed in this FDA 510(k) record. The listed applicant is Sober Ip, LLC. It received FDA 510(k) clearance on 2025-09-15 under 510(k) number K250609. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sober Self-Test?
Sober Self-Test is a medical device that received FDA 510(k) clearance on 2025-09-15. The listed applicant is Sober Ip, LLC. The 510(k) number is K250609.
When did Sober Self-Test receive FDA 510(k) clearance?
Sober Self-Test received FDA 510(k) clearance on 2025-09-15, under 510(k) number K250609.
Who is the listed applicant for Sober Self-Test?
The FDA 510(k) record lists Sober Ip, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sober Self-Test?
The FDA product code for Sober Self-Test is DIC.
相关临床试验
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相关器械（代码：DIC）
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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