X-trodes系统M
K号: K232210 · 2024-02-04
广告
申请人X-Trodes
决定日期2024-02-04
产品代码GWL
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
X-trodes System M is the device name listed in this FDA 510(k) record. The listed applicant is X-Trodes. It received FDA 510(k) clearance on 2024-02-04 under 510(k) number K232210. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the X-trodes System M?
X-trodes System M is a medical device that received FDA 510(k) clearance on 2024-02-04. The listed applicant is X-Trodes. The 510(k) number is K232210.
When did X-trodes System M receive FDA 510(k) clearance?
X-trodes System M received FDA 510(k) clearance on 2024-02-04, under 510(k) number K232210.
Who is the listed applicant for X-trodes System M?
The FDA 510(k) record lists X-Trodes as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-trodes System M?
The FDA product code for X-trodes System M is GWL.
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。
相关器械（代码：GWL）
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。
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。
广告