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FDA 510(k)

UNIVERSAL ELECTRODES

K-Number: K083818 · 2009-01-21

ApplicantNeurometrix, Inc.
Decision Date2009-01-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrix, Inc.. It received FDA 510(k) clearance on 2009-01-21 under 510(k) number K083818. 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 UNIVERSAL ELECTRODES?

UNIVERSAL ELECTRODES is a medical device that received FDA 510(k) clearance on 2009-01-21. The listed applicant is Neurometrix, Inc.. The 510(k) number is K083818.

When did UNIVERSAL ELECTRODES receive FDA 510(k) clearance?

UNIVERSAL ELECTRODES received FDA 510(k) clearance on 2009-01-21, under 510(k) number K083818.

Who is the listed applicant for UNIVERSAL ELECTRODES?

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

What is the FDA product code for UNIVERSAL ELECTRODES?

The FDA product code for UNIVERSAL ELECTRODES is GXY.

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Other records listing Neurometrix, Inc. 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.

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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

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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