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FDA 510(k)

GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE

K-Number: K071118 · 2007-09-07

ApplicantIves Eeg Solutions, Inc.
Decision Date2007-09-07
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ives Eeg Solutions, Inc.. It received FDA 510(k) clearance on 2007-09-07 under 510(k) number K071118. 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 GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE?

GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE is a medical device that received FDA 510(k) clearance on 2007-09-07. The listed applicant is Ives Eeg Solutions, Inc.. The 510(k) number is K071118.

When did GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE receive FDA 510(k) clearance?

GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE received FDA 510(k) clearance on 2007-09-07, under 510(k) number K071118.

Who is the listed applicant for GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE?

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

What is the FDA product code for GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE?

The FDA product code for GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE is GXY.

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Other records listing Ives Eeg Solutions, 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.

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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.

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Official Source

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