HepaFatSmart (V2.0.0)
K号: K231459 · 2023-06-20
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器械摘要
HepaFatSmart (V2.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K231459. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HepaFatSmart (V2.0.0)?
HepaFatSmart (V2.0.0) is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K231459.
When did HepaFatSmart (V2.0.0) receive FDA 510(k) clearance?
HepaFatSmart (V2.0.0) received FDA 510(k) clearance on 2023-06-20, under 510(k) number K231459.
Who is the listed applicant for HepaFatSmart (V2.0.0)?
The FDA 510(k) record lists Resonance Health Analysis Services Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HepaFatSmart (V2.0.0)?
The FDA product code for HepaFatSmart (V2.0.0) is LNH.
相关临床试验
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列明Resonance Health Analysis Services 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：LNH）
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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