Faros外科系统
K号: K233398 · 2024-06-27
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决定日期2024-06-27
产品代码HQC
咨询委员会OP
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决定实质等同
器械摘要
Faros Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Oertli Instrumente AG. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K233398. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Faros Surgical System?
Faros Surgical System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Oertli Instrumente AG. The 510(k) number is K233398.
When did Faros Surgical System receive FDA 510(k) clearance?
Faros Surgical System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K233398.
Who is the listed applicant for Faros Surgical System?
The FDA 510(k) record lists Oertli Instrumente AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Faros Surgical System?
The FDA product code for Faros Surgical System is HQC.
相关临床试验
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相关器械（代码：HQC）
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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