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FDA 510(k)

Sense System with IBT Electrodes

K-Number: K182112 · 2018-10-05

ApplicantInfinite Biomedical Technologies, LLC
Decision Date2018-10-05
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sense System with IBT Electrodes is a medical device manufactured by Infinite Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-10-05 under approval number K182112. 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 Sense System with IBT Electrodes?

Sense System with IBT Electrodes is a medical device that received FDA 510(k) clearance on 2018-10-05. It is manufactured by Infinite Biomedical Technologies, LLC. The 510(k) number is K182112.

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

Sense System with IBT Electrodes received FDA 510(k) clearance on 2018-10-05, under approval number K182112.

What company makes Sense System with IBT Electrodes?

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

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

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

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Related PubMed Literature

PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019)

Other Devices by Infinite Biomedical Technologies, LLC

K173571Element System with IBT Electrodes K240884Glide (91000-GL-X)

Related Devices (Code: 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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