CS Model+
K号: K193390 · 2020-04-02
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申请人Trophy
决定日期2020-04-02
产品代码PNN
咨询委员会DE
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决定实质等同
器械摘要
CS Model+ is the device name listed in this FDA 510(k) record. The listed applicant is Trophy. It received FDA 510(k) clearance on 2020-04-02 under 510(k) number K193390. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CS Model+?
CS Model+ is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Trophy. The 510(k) number is K193390.
When did CS Model+ receive FDA 510(k) clearance?
CS Model+ received FDA 510(k) clearance on 2020-04-02, under 510(k) number K193390.
Who is the listed applicant for CS Model+?
The FDA 510(k) record lists Trophy as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CS Model+?
The FDA product code for CS Model+ is PNN.
相关临床试验
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。
列明Trophy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：PNN）
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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