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FDA 510(k)

Element System with IBT Electrodes

K-Number: K173571 · 2018-03-21

ApplicantInfinite Biomedical Technologies, LLC
Decision Date2018-03-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Element System with IBT Electrodes is a medical device manufactured by Infinite Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-03-21 under approval number K173571. 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 Element System with IBT Electrodes?

Element System with IBT Electrodes is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Infinite Biomedical Technologies, LLC. The 510(k) number is K173571.

When was Element System with IBT Electrodes approved by the FDA?

Element System with IBT Electrodes received FDA 510(k) clearance on 2018-03-21, under approval number K173571.

What company makes Element System with IBT Electrodes?

Element System with IBT Electrodes is manufactured by Infinite Biomedical Technologies, LLC.

What is the FDA product code for Element System with IBT Electrodes?

The FDA product code for Element System with IBT Electrodes is GXY.

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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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