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FDA 510(k)

NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES

K-Number: K983597 · 1999-01-11

ApplicantMedicotest, Inc.
Decision Date1999-01-11
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Medicotest, Inc.. It received FDA 510(k) clearance on 1999-01-11 under 510(k) number K983597. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES?

NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES is a medical device that received FDA 510(k) clearance on 1999-01-11. The listed applicant is Medicotest, Inc.. The 510(k) number is K983597.

When did NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES receive FDA 510(k) clearance?

NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES received FDA 510(k) clearance on 1999-01-11, under 510(k) number K983597.

Who is the listed applicant for NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES?

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 MONOPOLAR NEEDLE ELECTRODES?

The FDA product code for NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES is GXZ.

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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.

K970639NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-KK961643MEDICOTEST ECG ELECTRODESK952176DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-KK941568K-10-VS, DA-05-VS, RECORDING ELECTRODESK931426NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODEK931430CUTANEOUS ELECTRODE

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Related Devices (Code: GXZ)

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.

K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed EuropeK232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.K200984Guardian Needle ElectrodeRhythmlink International, LLCK192603Spes Medica Subdermal Needle ElectrodesSpes Medica SrlK190801PressOn Electrode HeadsetRhythmlink International, LLC

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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