Inessa 系统
K号: K230545 · 2023-12-20
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决定日期2023-12-20
产品代码QFG
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Inessa System is the device name listed in this FDA 510(k) record. The listed applicant is Triple Jump Israel , Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K230545. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Inessa System?
Inessa System is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Triple Jump Israel , Ltd.. The 510(k) number is K230545.
When did Inessa System receive FDA 510(k) clearance?
Inessa System received FDA 510(k) clearance on 2023-12-20, under 510(k) number K230545.
Who is the listed applicant for Inessa System?
The FDA 510(k) record lists Triple Jump Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Inessa System?
The FDA product code for Inessa System is QFG.
相关临床试验
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相关器械（代码：QFG）
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
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