Premier 分解系统
K号: K222635 · 2023-08-04
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决定日期2023-08-04
产品代码GKA
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Premier Resolution System is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech (Primus Corporation, Dba Trinity Biotech). It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K222635. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Premier Resolution System?
Premier Resolution System is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Trinity Biotech (Primus Corporation, Dba Trinity Biotech). The 510(k) number is K222635.
When did Premier Resolution System receive FDA 510(k) clearance?
Premier Resolution System received FDA 510(k) clearance on 2023-08-04, under 510(k) number K222635.
Who is the listed applicant for Premier Resolution System?
The FDA 510(k) record lists Trinity Biotech (Primus Corporation, Dba Trinity Biotech) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Premier Resolution System?
The FDA product code for Premier Resolution System is GKA.
相关临床试验
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相关器械（代码：GKA）
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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