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FDA 510(k)

ELECTRODE ARRAY CAP

K-Number: K071446 · 2008-07-02

Decision Date2008-07-02
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRODE ARRAY CAP is the device name listed in this FDA 510(k) record. The listed applicant is Electrode Arrays. It received FDA 510(k) clearance on 2008-07-02 under 510(k) number K071446. 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 ELECTRODE ARRAY CAP?

ELECTRODE ARRAY CAP is a medical device that received FDA 510(k) clearance on 2008-07-02. The listed applicant is Electrode Arrays. The 510(k) number is K071446.

When did ELECTRODE ARRAY CAP receive FDA 510(k) clearance?

ELECTRODE ARRAY CAP received FDA 510(k) clearance on 2008-07-02, under 510(k) number K071446.

Who is the listed applicant for ELECTRODE ARRAY CAP?

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

What is the FDA product code for ELECTRODE ARRAY CAP?

The FDA product code for ELECTRODE ARRAY CAP is GXY.

Related Clinical Trials

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.

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.

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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