NeoNavia 活检系统
K号: K220595 · 2022-09-08
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决定日期2022-09-08
产品代码KNW
咨询委员会GU
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决定实质等同
器械摘要
NeoNavia Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Neodynamics AB. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K220595. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NeoNavia Biopsy System?
NeoNavia Biopsy System is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Neodynamics AB. The 510(k) number is K220595.
When did NeoNavia Biopsy System receive FDA 510(k) clearance?
NeoNavia Biopsy System received FDA 510(k) clearance on 2022-09-08, under 510(k) number K220595.
Who is the listed applicant for NeoNavia Biopsy System?
The FDA 510(k) record lists Neodynamics AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NeoNavia Biopsy System?
The FDA product code for NeoNavia Biopsy System is KNW.
相关临床试验
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。
相关器械（代码：KNW）
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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