ArtiFascia
K号: K223445 · 2023-08-10
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决定日期2023-08-10
产品代码GXQ
咨询委员会NE
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决定实质等同
器械摘要
ArtiFascia is the device name listed in this FDA 510(k) record. The listed applicant is Nurami Medical , Ltd.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K223445. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ArtiFascia?
ArtiFascia is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Nurami Medical , Ltd.. The 510(k) number is K223445.
When did ArtiFascia receive FDA 510(k) clearance?
ArtiFascia received FDA 510(k) clearance on 2023-08-10, under 510(k) number K223445.
Who is the listed applicant for ArtiFascia?
The FDA 510(k) record lists Nurami Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ArtiFascia?
The FDA product code for ArtiFascia is GXQ.
相关临床试验
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相关器械（代码：GXQ）
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
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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