TNI softFlow 50
K号: K180474 · 2018-10-18
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决定日期2018-10-18
产品代码BTT
咨询委员会AN
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决定实质等同
器械摘要
TNI softFlow 50 is the device name listed in this FDA 510(k) record. The listed applicant is Tni Medical AG. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K180474. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TNI softFlow 50?
TNI softFlow 50 is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Tni Medical AG. The 510(k) number is K180474.
When did TNI softFlow 50 receive FDA 510(k) clearance?
TNI softFlow 50 received FDA 510(k) clearance on 2018-10-18, under 510(k) number K180474.
Who is the listed applicant for TNI softFlow 50?
The FDA 510(k) record lists Tni Medical AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TNI softFlow 50?
The FDA product code for TNI softFlow 50 is BTT.
相关临床试验
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相关器械（代码：BTT）
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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