Revogene
K号: K170558 · 2017-05-25
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决定日期2017-05-25
产品代码OOI
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
revogene is the device name listed in this FDA 510(k) record. The listed applicant is Genepoc, Inc.. It received FDA 510(k) clearance on 2017-05-25 under 510(k) number K170558. The device is classified under product code OOI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the revogene?
revogene is a medical device that received FDA 510(k) clearance on 2017-05-25. The listed applicant is Genepoc, Inc.. The 510(k) number is K170558.
When did revogene receive FDA 510(k) clearance?
revogene received FDA 510(k) clearance on 2017-05-25, under 510(k) number K170558.
Who is the listed applicant for revogene?
The FDA 510(k) record lists Genepoc, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for revogene?
The FDA product code for revogene is OOI.
相关临床试验
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列明Genepoc, Inc.为申报人的其他记录
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相关器械（代码：OOI）
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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