System Sophi
K号: K250501 · 2025-11-14
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申请人This AG
决定日期2025-11-14
产品代码HQC
咨询委员会OP
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决定实质等同
器械摘要
System Sophi is the device name listed in this FDA 510(k) record. The listed applicant is This AG. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K250501. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the System Sophi?
System Sophi is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is This AG. The 510(k) number is K250501.
When did System Sophi receive FDA 510(k) clearance?
System Sophi received FDA 510(k) clearance on 2025-11-14, under 510(k) number K250501.
Who is the listed applicant for System Sophi?
The FDA 510(k) record lists This AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for System Sophi?
The FDA product code for System Sophi is HQC.
相关临床试验
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相关器械（代码：HQC）
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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