Sentimag System
K号: K222832 · 2023-01-21
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决定日期2023-01-21
产品代码NEU
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Sentimag System is the device name listed in this FDA 510(k) record. The listed applicant is Endomagnetics Ltd.,. It received FDA 510(k) clearance on 2023-01-21 under 510(k) number K222832. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sentimag System?
Sentimag System is a medical device that received FDA 510(k) clearance on 2023-01-21. The listed applicant is Endomagnetics Ltd.,. The 510(k) number is K222832.
When did Sentimag System receive FDA 510(k) clearance?
Sentimag System received FDA 510(k) clearance on 2023-01-21, under 510(k) number K222832.
Who is the listed applicant for Sentimag System?
The FDA 510(k) record lists Endomagnetics Ltd., as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sentimag System?
The FDA product code for Sentimag System is NEU.
相关临床试验
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列明Endomagnetics 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：NEU）
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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