VisioFocus Mini，VisioFocus 智能
K号: K160680 · 2017-04-19
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决定日期2017-04-19
产品代码FLL
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
VisioFocus Mini, VisioFocus Smart is the device name listed in this FDA 510(k) record. The listed applicant is Tecnimed S.R.L.. It received FDA 510(k) clearance on 2017-04-19 under 510(k) number K160680. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VisioFocus Mini, VisioFocus Smart?
VisioFocus Mini, VisioFocus Smart is a medical device that received FDA 510(k) clearance on 2017-04-19. The listed applicant is Tecnimed S.R.L.. The 510(k) number is K160680.
When did VisioFocus Mini, VisioFocus Smart receive FDA 510(k) clearance?
VisioFocus Mini, VisioFocus Smart received FDA 510(k) clearance on 2017-04-19, under 510(k) number K160680.
Who is the listed applicant for VisioFocus Mini, VisioFocus Smart?
The FDA 510(k) record lists Tecnimed S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VisioFocus Mini, VisioFocus Smart?
The FDA product code for VisioFocus Mini, VisioFocus Smart is FLL.
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。
相关器械（代码：FLL）
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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