Trusana™
K号: K230098 · 2023-04-13
广告
申请人Myerson, LLC
决定日期2023-04-13
产品代码EBI
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
Trusana™ is the device name listed in this FDA 510(k) record. The listed applicant is Myerson, LLC. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K230098. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Trusana™?
Trusana™ is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Myerson, LLC. The 510(k) number is K230098.
When did Trusana™ receive FDA 510(k) clearance?
Trusana™ received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230098.
Who is the listed applicant for Trusana™?
The FDA 510(k) record lists Myerson, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Trusana™?
The FDA product code for Trusana™ is EBI.
相关临床试验
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：EBI）
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。
广告