NinesAI
K号: K193351 · 2020-04-21
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器械摘要
NinesAI is the device name listed in this FDA 510(k) record. The listed applicant is Nines, Inc.. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K193351. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NinesAI?
NinesAI is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Nines, Inc.. The 510(k) number is K193351.
When did NinesAI receive FDA 510(k) clearance?
NinesAI received FDA 510(k) clearance on 2020-04-21, under 510(k) number K193351.
Who is the listed applicant for NinesAI?
The FDA 510(k) record lists Nines, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NinesAI?
The FDA product code for NinesAI is QAS.
相关临床试验
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列明Nines, Inc.为申报人的其他记录
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相关器械（代码：QAS）
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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