ELEC 发动机（型号：ISE-170L）
K号: K231562 · 2025-07-18
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决定日期2025-07-18
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 ENGINE (Model: ISE-170L) 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 2025-07-18 under 510(k) number K231562. 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 ENGINE (Model: ISE-170L)?
ELEC ENGINE (Model: ISE-170L) is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Micro-Nx Co., Ltd.. The 510(k) number is K231562.
When did ELEC ENGINE (Model: ISE-170L) receive FDA 510(k) clearance?
ELEC ENGINE (Model: ISE-170L) received FDA 510(k) clearance on 2025-07-18, under 510(k) number K231562.
Who is the listed applicant for ELEC ENGINE (Model: ISE-170L)?
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 ENGINE (Model: ISE-170L)?
The FDA product code for ELEC ENGINE (Model: ISE-170L) is EBW.
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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