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FDA 510(k)

NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K

K-Number: K970639 · 1997-05-15

ApplicantMedicotest, Inc.
Decision Date1997-05-15
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K is the device name listed in this FDA 510(k) record. The listed applicant is Medicotest, Inc.. It received FDA 510(k) clearance on 1997-05-15 under 510(k) number K970639. 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 NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K?

NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K is a medical device that received FDA 510(k) clearance on 1997-05-15. The listed applicant is Medicotest, Inc.. The 510(k) number is K970639.

When did NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K receive FDA 510(k) clearance?

NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K received FDA 510(k) clearance on 1997-05-15, under 510(k) number K970639.

Who is the listed applicant for NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K?

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

What is the FDA product code for NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K?

The FDA product code for NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K is GXY.

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Other records listing Medicotest, 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.

K983597NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODESK961643MEDICOTEST ECG ELECTRODESK952176DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-KK941568K-10-VS, DA-05-VS, RECORDING ELECTRODESK931430CUTANEOUS ELECTRODEK931426NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE

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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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