APrioCore Plus
K号: K193268 · 2020-02-27
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申请人Apriomed AB
决定日期2020-02-27
产品代码KNW
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
APrioCore Plus is the device name listed in this FDA 510(k) record. The listed applicant is Apriomed AB. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K193268. 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 APrioCore Plus?
APrioCore Plus is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Apriomed AB. The 510(k) number is K193268.
When did APrioCore Plus receive FDA 510(k) clearance?
APrioCore Plus received FDA 510(k) clearance on 2020-02-27, under 510(k) number K193268.
Who is the listed applicant for APrioCore Plus?
The FDA 510(k) record lists Apriomed AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for APrioCore Plus?
The FDA product code for APrioCore Plus 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。
列明Apriomed AB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。
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
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