Forma 系统，Forma 光系统
K号: K160195 · 2016-04-15
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决定日期2016-04-15
产品代码ONF
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
Forma System, Forma Light System is the device name listed in this FDA 510(k) record. The listed applicant is Formatk Systems , Ltd.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K160195. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Forma System, Forma Light System?
Forma System, Forma Light System is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Formatk Systems , Ltd.. The 510(k) number is K160195.
When did Forma System, Forma Light System receive FDA 510(k) clearance?
Forma System, Forma Light System received FDA 510(k) clearance on 2016-04-15, under 510(k) number K160195.
Who is the listed applicant for Forma System, Forma Light System?
The FDA 510(k) record lists Formatk Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Forma System, Forma Light System?
The FDA product code for Forma System, Forma Light System is ONF.
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Formatk Systems , 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：ONF）
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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