Brainlab Elements Guide XT, Guide 3.0
K号: K213930 · 2022-04-19
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申请人Brainlab AG
决定日期2022-04-19
产品代码QQC
咨询委员会NE
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决定实质等同
器械摘要
Brainlab Elements Guide XT, Guide 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2022-04-19 under 510(k) number K213930. The device is classified under product code QQC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Brainlab Elements Guide XT, Guide 3.0?
Brainlab Elements Guide XT, Guide 3.0 is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Brainlab AG. The 510(k) number is K213930.
When did Brainlab Elements Guide XT, Guide 3.0 receive FDA 510(k) clearance?
Brainlab Elements Guide XT, Guide 3.0 received FDA 510(k) clearance on 2022-04-19, under 510(k) number K213930.
Who is the listed applicant for Brainlab Elements Guide XT, Guide 3.0?
The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Brainlab Elements Guide XT, Guide 3.0?
The FDA product code for Brainlab Elements Guide XT, Guide 3.0 is QQC.
相关临床试验
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列明Brainlab AG为申报人的其他记录
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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相关器械（代码：QQC）
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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