ELEXIR 2.0 (ALLIVE3)
K号: K242719 · 2024-11-06
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决定日期2024-11-06
产品代码PCC
咨询委员会NE
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决定实质等同
器械摘要
ELEXIR 2.0 (ALLIVE3) is the device name listed in this FDA 510(k) record. The listed applicant is Nu Eyne Co., Ltd.. It received FDA 510(k) clearance on 2024-11-06 under 510(k) number K242719. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ELEXIR 2.0 (ALLIVE3)?
ELEXIR 2.0 (ALLIVE3) is a medical device that received FDA 510(k) clearance on 2024-11-06. The listed applicant is Nu Eyne Co., Ltd.. The 510(k) number is K242719.
When did ELEXIR 2.0 (ALLIVE3) receive FDA 510(k) clearance?
ELEXIR 2.0 (ALLIVE3) received FDA 510(k) clearance on 2024-11-06, under 510(k) number K242719.
Who is the listed applicant for ELEXIR 2.0 (ALLIVE3)?
The FDA 510(k) record lists Nu Eyne Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELEXIR 2.0 (ALLIVE3)?
The FDA product code for ELEXIR 2.0 (ALLIVE3) is PCC.
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列明Nu Eyne Co., Ltd.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：PCC）
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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