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FDA 510(k)

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96

K-Number: K163547 · 2017-04-11

ApplicantNeurovirtual USA, Inc.
Decision Date2017-04-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 is a medical device manufactured by Neurovirtual USA, Inc.. It received FDA 510(k) clearance on 2017-04-11 under approval number K163547. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96?

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 is a medical device that received FDA 510(k) clearance on 2017-04-11. It is manufactured by Neurovirtual USA, Inc.. The 510(k) number is K163547.

When was MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 approved by the FDA?

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 received FDA 510(k) clearance on 2017-04-11, under approval number K163547.

What company makes MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96?

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 is manufactured by Neurovirtual USA, Inc..

What is the FDA product code for MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96?

The FDA product code for MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 is GXY.

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Official Source

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

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