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FDA 510(k)

SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY

K-Number: K022197 · 2002-08-13

ApplicantThe Electrode Store, Inc.
Decision Date2002-08-13
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY 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 2002-08-13 under 510(k) number K022197. 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 SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY?

SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY is a medical device that received FDA 510(k) clearance on 2002-08-13. The listed applicant is The Electrode Store, Inc.. The 510(k) number is K022197.

When did SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY receive FDA 510(k) clearance?

SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY received FDA 510(k) clearance on 2002-08-13, under 510(k) number K022197.

Who is the listed applicant for SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY?

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 SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY?

The FDA product code for SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY is GXY.

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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 STIMULATORSK020910SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAFK020445THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMGK926094PROTECTRODE SYSTEMK932691PROTECTRODE SYSTEMS CONCENTRIC

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.

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Official Source

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