Smart One
K号: K181666 · 2018-08-01
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决定日期2018-08-01
产品代码BZH
咨询委员会AN
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器械摘要
Smart One is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical International Research. It received FDA 510(k) clearance on 2018-08-01 under 510(k) number K181666. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Smart One?
Smart One is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Mir Medical International Research. The 510(k) number is K181666.
When did Smart One receive FDA 510(k) clearance?
Smart One received FDA 510(k) clearance on 2018-08-01, under 510(k) number K181666.
Who is the listed applicant for Smart One?
The FDA 510(k) record lists Mir Medical International Research as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Smart One?
The FDA product code for Smart One is BZH.
相关临床试验
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相关器械（代码：BZH）
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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