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FDA 510(k)

EEG ELECTRODES

K-Number: K962283 · 1996-12-16

ApplicantTeca, Inc.
Decision Date1996-12-16
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1996-12-16 under 510(k) number K962283. 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 EEG ELECTRODES?

EEG ELECTRODES is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Teca, Inc.. The 510(k) number is K962283.

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

EEG ELECTRODES received FDA 510(k) clearance on 1996-12-16, under 510(k) number K962283.

Who is the listed applicant for EEG ELECTRODES?

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

What is the FDA product code for EEG ELECTRODES?

The FDA product code for EEG ELECTRODES is GXY.

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Other records listing Teca, 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.

K903731SAPPHIRE SERIES 1P, 1L, 2L, AND 2MEK903004EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPHK896666P460, DG32 ELECTROENCEPHALOGRAPHK894889TECA NEUROMAPPER 386K894088TECA NEUROMAPPER 1620, BRAIN MAPPERK890881TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS

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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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