iPhysio® 系统
K号: K232383 · 2025-03-04
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申请人Euroteknika
决定日期2025-03-04
产品代码NHA
咨询委员会DE
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决定实质等同
器械摘要
iPhysio® System is the device name listed in this FDA 510(k) record. The listed applicant is Euroteknika. It received FDA 510(k) clearance on 2025-03-04 under 510(k) number K232383. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iPhysio® System?
iPhysio® System is a medical device that received FDA 510(k) clearance on 2025-03-04. The listed applicant is Euroteknika. The 510(k) number is K232383.
When did iPhysio® System receive FDA 510(k) clearance?
iPhysio® System received FDA 510(k) clearance on 2025-03-04, under 510(k) number K232383.
Who is the listed applicant for iPhysio® System?
The FDA 510(k) record lists Euroteknika as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iPhysio® System?
The FDA product code for iPhysio® System is NHA.
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：NHA）
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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