Therm-X
K号: K231912 · 2023-07-27
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决定日期2023-07-27
产品代码IRP
咨询委员会PM
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决定实质等同
器械摘要
Therm-X is the device name listed in this FDA 510(k) record. The listed applicant is Zenith Technical Innovations. It received FDA 510(k) clearance on 2023-07-27 under 510(k) number K231912. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Therm-X?
Therm-X is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is Zenith Technical Innovations. The 510(k) number is K231912.
When did Therm-X receive FDA 510(k) clearance?
Therm-X received FDA 510(k) clearance on 2023-07-27, under 510(k) number K231912.
Who is the listed applicant for Therm-X?
The FDA 510(k) record lists Zenith Technical Innovations as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Therm-X?
The FDA product code for Therm-X is IRP.
相关临床试验
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列明Zenith Technical Innovations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：IRP）
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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