UNITY DX (UDX)
K号: K252633 · 2025-12-23
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决定日期2025-12-23
产品代码OBO
咨询委员会OP
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决定实质等同
器械摘要
UNITY DX (UDX) is the device name listed in this FDA 510(k) record. The listed applicant is Cylite Pty. , Ltd.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K252633. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UNITY DX (UDX)?
UNITY DX (UDX) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Cylite Pty. , Ltd.. The 510(k) number is K252633.
When did UNITY DX (UDX) receive FDA 510(k) clearance?
UNITY DX (UDX) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K252633.
Who is the listed applicant for UNITY DX (UDX)?
The FDA 510(k) record lists Cylite Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UNITY DX (UDX)?
The FDA product code for UNITY DX (UDX) is OBO.
相关临床试验
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列明Cylite Pty. , Ltd.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：OBO）
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
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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