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FDA 510(k)

BRAINSTREAM Disposable Deep Cup EEG Electrodes

K-Number: K200540 · 2020-06-01

ApplicantConmed Corporation
Decision Date2020-06-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINSTREAM Disposable Deep Cup EEG Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K200540. 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 BRAINSTREAM Disposable Deep Cup EEG Electrodes?

BRAINSTREAM Disposable Deep Cup EEG Electrodes is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Conmed Corporation. The 510(k) number is K200540.

When did BRAINSTREAM Disposable Deep Cup EEG Electrodes receive FDA 510(k) clearance?

BRAINSTREAM Disposable Deep Cup EEG Electrodes received FDA 510(k) clearance on 2020-06-01, under 510(k) number K200540.

Who is the listed applicant for BRAINSTREAM Disposable Deep Cup EEG Electrodes?

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

What is the FDA product code for BRAINSTREAM Disposable Deep Cup EEG Electrodes?

The FDA product code for BRAINSTREAM Disposable Deep Cup EEG Electrodes is GXY.

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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.

K260578Ambu® 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 EuropeK252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.

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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