Q-Pad Test System
K号: K231465 · 2023-12-06
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申请人Qurasense
决定日期2023-12-06
产品代码LCP
咨询委员会HE
请注意,由于您只提供了“HE”作为输入,我无法提供完整的翻译。请提供完整的描述或文本,以便我能够进行准确的翻译。
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器械摘要
Q-Pad Test System is the device name listed in this FDA 510(k) record. The listed applicant is Qurasense. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K231465. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Q-Pad Test System?
Q-Pad Test System is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Qurasense. The 510(k) number is K231465.
When did Q-Pad Test System receive FDA 510(k) clearance?
Q-Pad Test System received FDA 510(k) clearance on 2023-12-06, under 510(k) number K231465.
Who is the listed applicant for Q-Pad Test System?
The FDA 510(k) record lists Qurasense as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Q-Pad Test System?
The FDA product code for Q-Pad Test System is LCP.
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相关器械(代码:LCP)
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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