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FDA 510(k)

INTERX500 FLEXIBLE ARRAY ELECTRODE

K-Number: K053626 · 2006-03-29

ApplicantNeuro Resource Group, Inc.
Decision Date2006-03-29
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTERX500 FLEXIBLE ARRAY ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Resource Group, Inc.. It received FDA 510(k) clearance on 2006-03-29 under 510(k) number K053626. 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 INTERX500 FLEXIBLE ARRAY ELECTRODE?

INTERX500 FLEXIBLE ARRAY ELECTRODE is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is Neuro Resource Group, Inc.. The 510(k) number is K053626.

When did INTERX500 FLEXIBLE ARRAY ELECTRODE receive FDA 510(k) clearance?

INTERX500 FLEXIBLE ARRAY ELECTRODE received FDA 510(k) clearance on 2006-03-29, under 510(k) number K053626.

Who is the listed applicant for INTERX500 FLEXIBLE ARRAY ELECTRODE?

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

What is the FDA product code for INTERX500 FLEXIBLE ARRAY ELECTRODE?

The FDA product code for INTERX500 FLEXIBLE ARRAY ELECTRODE is GXY.

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Other records listing Neuro Resource Group, 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.

K130816INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)K070217INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USEK042912INTERX5000

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

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