CoreLevee
K号: K213748 · 2022-10-14
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决定日期2022-10-14
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
CoreLevee is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K213748. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CoreLevee?
CoreLevee is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Lutronic Corporation. The 510(k) number is K213748.
When did CoreLevee receive FDA 510(k) clearance?
CoreLevee received FDA 510(k) clearance on 2022-10-14, under 510(k) number K213748.
Who is the listed applicant for CoreLevee?
The FDA 510(k) record lists Lutronic Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoreLevee?
The FDA product code for CoreLevee is NGX.
相关临床试验
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列明Lutronic Corporation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：NGX）
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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