SMARTmatic
K号: K163239 · 2017-03-17
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决定日期2017-03-17
产品代码EFA
咨询委员会DE
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决定实质等同
器械摘要
SMARTmatic is the device name listed in this FDA 510(k) record. The listed applicant is Kaltenbach & Voigt GmbH. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K163239. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SMARTmatic?
SMARTmatic is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Kaltenbach & Voigt GmbH. The 510(k) number is K163239.
When did SMARTmatic receive FDA 510(k) clearance?
SMARTmatic received FDA 510(k) clearance on 2017-03-17, under 510(k) number K163239.
Who is the listed applicant for SMARTmatic?
The FDA 510(k) record lists Kaltenbach & Voigt GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SMARTmatic?
The FDA product code for SMARTmatic is EFA.
相关临床试验
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列明Kaltenbach & Voigt GmbH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：EFA）
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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