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FDA 510(k)

SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF

K-Number: K020910 · 2002-07-19

ApplicantThe Electrode Store, Inc.
Decision Date2002-07-19
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF is the device name listed in this FDA 510(k) record. The listed applicant is The Electrode Store, Inc.. It received FDA 510(k) clearance on 2002-07-19 under 510(k) number K020910. 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 SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF?

SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF is a medical device that received FDA 510(k) clearance on 2002-07-19. The listed applicant is The Electrode Store, Inc.. The 510(k) number is K020910.

When did SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF receive FDA 510(k) clearance?

SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF received FDA 510(k) clearance on 2002-07-19, under 510(k) number K020910.

Who is the listed applicant for SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF?

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

What is the FDA product code for SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF?

The FDA product code for SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF is GXZ.

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Other records listing The Electrode Store, 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.

K083758SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORSK022197SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHYK020445THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMGK926094PROTECTRODE SYSTEMK932691PROTECTRODE SYSTEMS CONCENTRIC

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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