FDA 510(k)

SUBDERMAL WIRE ELECTRODE, MODEL SWE

K-Number: K062880 · 2006-12-22

Decision Date2006-12-22

Product CodeGXZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SUBDERMAL WIRE ELECTRODE, MODEL SWE 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 2006-12-22 under 510(k) number K062880. 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 WIRE ELECTRODE, MODEL SWE?

SUBDERMAL WIRE ELECTRODE, MODEL SWE is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Ives Eeg Solutions, Inc.. The 510(k) number is K062880.

When did SUBDERMAL WIRE ELECTRODE, MODEL SWE receive FDA 510(k) clearance?

SUBDERMAL WIRE ELECTRODE, MODEL SWE received FDA 510(k) clearance on 2006-12-22, under 510(k) number K062880.

Who is the listed applicant for SUBDERMAL WIRE ELECTRODE, MODEL SWE?

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 SUBDERMAL WIRE ELECTRODE, MODEL SWE?

The FDA product code for SUBDERMAL WIRE ELECTRODE, MODEL SWE is GXZ.

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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.