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FDA 510(k)

EEG ELECTRODES

K-Number: K841685 · 1984-06-07

ApplicantBio-Scan, Inc.
Decision Date1984-06-07
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 Bio-Scan, Inc.. It received FDA 510(k) clearance on 1984-06-07 under 510(k) number K841685. 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 1984-06-07. The listed applicant is Bio-Scan, Inc.. The 510(k) number is K841685.

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

EEG ELECTRODES received FDA 510(k) clearance on 1984-06-07, under 510(k) number K841685.

Who is the listed applicant for EEG ELECTRODES?

The FDA 510(k) record lists Bio-Scan, 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.

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.

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Other records listing Bio-Scan, 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.

K003480BIOFINDK925735EEG ANALYZERK864928BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDERK841683Q.P. PREAMPLIFIER SYSK841684BIO/SCAN BIOLOG CASSETTE RECORDER

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

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