Elexir
K号: K211380 · 2021-07-30
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决定日期2021-07-30
产品代码PCC
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Elexir 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 2021-07-30 under 510(k) number K211380. 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?
Elexir is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Nu Eyne Co., Ltd.. The 510(k) number is K211380.
When did Elexir receive FDA 510(k) clearance?
Elexir received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211380.
Who is the listed applicant for Elexir?
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?
The FDA product code for Elexir is PCC.
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。
K254216Enso for MigraineHinge Health, Inc.K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K234029CEFALY Connected - OTC，CEFALY Connected - RxCefaly TechnologyK232749DOOPANGYbrain, Inc.K233751Milieve (YPS-301BD)Soterix Medical, Inc.K230782经皮神经电刺激（TENS）设备-HeadaTerm 2（型号：YF-HT2）Wat Medical Technology, Inc.
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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