E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
K号: K202148 · 2021-08-25
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决定日期2021-08-25
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) is the device name listed in this FDA 510(k) record. The listed applicant is Fit-Pro , Ltd.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K202148. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)?
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Fit-Pro , Ltd.. The 510(k) number is K202148.
When did E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) receive FDA 510(k) clearance?
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) received FDA 510(k) clearance on 2021-08-25, under 510(k) number K202148.
Who is the listed applicant for E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)?
The FDA 510(k) record lists Fit-Pro , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)?
The FDA product code for E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) is NGX.
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相关器械（代码：NGX）
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
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