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FDA 510(k)

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

K-Number: K202148 · 2021-08-25

ApplicantFit-Pro , Ltd.
Decision Date2021-08-25
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) is a medical device manufactured by Fit-Pro , Ltd.. It received FDA 510(k) clearance on 2021-08-25 under approval number K202148. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Fit-Pro , Ltd.. The 510(k) number is K202148.

When was E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) approved by the FDA?

E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) received FDA 510(k) clearance on 2021-08-25, under approval number K202148.

What company makes E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)?

E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) is manufactured by Fit-Pro , Ltd..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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