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FDA 510(k)

FX Contra

K-Number: K222518 · 2022-11-17

ApplicantNakanishi, Inc.
Decision Date2022-11-17
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FX Contra is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K222518. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FX Contra?

FX Contra is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Nakanishi, Inc.. The 510(k) number is K222518.

When did FX Contra receive FDA 510(k) clearance?

FX Contra received FDA 510(k) clearance on 2022-11-17, under 510(k) number K222518.

Who is the listed applicant for FX Contra?

The FDA 510(k) record lists Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FX Contra?

The FDA product code for FX Contra is EGS.

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Related Devices (Code: EGS)

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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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