7D手术系统 - 经皮应用（7D Flash Frame）
K号: K220522 · 2022-05-20
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申请人7D Surgical
决定日期2022-05-20
产品代码OLO
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。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
7D Surgical System - Percutaneous Application (7D Flash Frame) is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K220522. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 7D Surgical System - Percutaneous Application (7D Flash Frame)?
7D Surgical System - Percutaneous Application (7D Flash Frame) is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is 7D Surgical. The 510(k) number is K220522.
When did 7D Surgical System - Percutaneous Application (7D Flash Frame) receive FDA 510(k) clearance?
7D Surgical System - Percutaneous Application (7D Flash Frame) received FDA 510(k) clearance on 2022-05-20, under 510(k) number K220522.
Who is the listed applicant for 7D Surgical System - Percutaneous Application (7D Flash Frame)?
The FDA 510(k) record lists 7D Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame)?
The FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame) is OLO.
相关临床试验
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相关器械（代码：OLO）
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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