ELEC-LED
K号: K201191 · 2022-02-07
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决定日期2022-02-07
产品代码EBW
咨询委员会DE
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决定实质等同
器械摘要
ELEC-LED is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2022-02-07 under 510(k) number K201191. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ELEC-LED?
ELEC-LED is a medical device that received FDA 510(k) clearance on 2022-02-07. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K201191.
When did ELEC-LED receive FDA 510(k) clearance?
ELEC-LED received FDA 510(k) clearance on 2022-02-07, under 510(k) number K201191.
Who is the listed applicant for ELEC-LED?
The FDA 510(k) record lists Micro-Nx Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELEC-LED?
The FDA product code for ELEC-LED is EBW.
列明Micro-Nx 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：EBW）
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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