CaloPix
K号: K250414 · 2025-05-14
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决定日期2025-05-14
产品代码QKQ
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
CaloPix is the device name listed in this FDA 510(k) record. The listed applicant is Tribun Health. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K250414. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CaloPix?
CaloPix is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Tribun Health. The 510(k) number is K250414.
When did CaloPix receive FDA 510(k) clearance?
CaloPix received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250414.
Who is the listed applicant for CaloPix?
The FDA 510(k) record lists Tribun Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CaloPix?
The FDA product code for CaloPix is QKQ.
相关临床试验
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相关器械（代码：QKQ）
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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