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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 the device name listed in this FDA 510(k) record. The listed applicant is Infinite Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-03-21 under 510(k) 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. The listed applicant is Infinite Biomedical Technologies, LLC. The 510(k) number is K173571.

When did Element System with IBT Electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for Element System with IBT Electrodes?

The FDA 510(k) record lists Infinite Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06539936Regulatory Clearance of the Glide Control Strategy for Upper Limb ProsthesesRECRUITING

Other records listing Infinite Biomedical Technologies, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240884Glide (91000-GL-X)K182112Sense System with IBT Electrodes

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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