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FDA 510(k)

SENSUS ELECTRODE

K-Number: K121816 · 2012-11-26

ApplicantNeurometrix, Inc.
Decision Date2012-11-26
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SENSUS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrix, Inc.. It received FDA 510(k) clearance on 2012-11-26 under 510(k) number K121816. 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 SENSUS ELECTRODE?

SENSUS ELECTRODE is a medical device that received FDA 510(k) clearance on 2012-11-26. The listed applicant is Neurometrix, Inc.. The 510(k) number is K121816.

When did SENSUS ELECTRODE receive FDA 510(k) clearance?

SENSUS ELECTRODE received FDA 510(k) clearance on 2012-11-26, under 510(k) number K121816.

Who is the listed applicant for SENSUS ELECTRODE?

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 SENSUS ELECTRODE?

The FDA product code for SENSUS ELECTRODE 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.

K152954QuellK130919SENSUSK121184SENSUSK091155ASCENDK083322NEUROMETRIX BIOAMPLIFIERK083818UNIVERSAL ELECTRODES

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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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

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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