FDA 510(k)

E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)

Número K: K202148 · 2021-08-25

Data da decisão2021-08-25

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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