生物反馈和刺激系统
K号: K222201 · 2022-10-21
广告
决定日期2022-10-21
产品代码IPF
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Biological Feedback and Stimulation System is the device name listed in this FDA 510(k) record. The listed applicant is Medlander Medical Technology, Inc.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K222201. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Biological Feedback and Stimulation System?
Biological Feedback and Stimulation System is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Medlander Medical Technology, Inc.. The 510(k) number is K222201.
When did Biological Feedback and Stimulation System receive FDA 510(k) clearance?
Biological Feedback and Stimulation System received FDA 510(k) clearance on 2022-10-21, under 510(k) number K222201.
Who is the listed applicant for Biological Feedback and Stimulation System?
The FDA 510(k) record lists Medlander Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Biological Feedback and Stimulation System?
The FDA product code for Biological Feedback and Stimulation System is IPF.
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：IPF）
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