AmplifEYE
K号: K160846 · 2016-07-14
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决定日期2016-07-14
产品代码FED
咨询委员会GU
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决定实质等同
器械摘要
AmplifEYE is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160846. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AmplifEYE?
AmplifEYE is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Medivators, Inc.. The 510(k) number is K160846.
When did AmplifEYE receive FDA 510(k) clearance?
AmplifEYE received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160846.
Who is the listed applicant for AmplifEYE?
The FDA 510(k) record lists Medivators, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AmplifEYE?
The FDA product code for AmplifEYE is FED.
相关临床试验
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列明Medivators, Inc.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：FED）
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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