Trinias
K号: K203535 · 2021-04-28
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器械摘要
Trinias is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation Medical Systems. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K203535. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Trinias?
Trinias is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Shimadzu Corporation Medical Systems. The 510(k) number is K203535.
When did Trinias receive FDA 510(k) clearance?
Trinias received FDA 510(k) clearance on 2021-04-28, under 510(k) number K203535.
Who is the listed applicant for Trinias?
The FDA 510(k) record lists Shimadzu Corporation Medical Systems as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Trinias?
The FDA product code for Trinias is OWB.
相关临床试验
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相关器械（代码：OWB）
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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