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FDA 510(k)

INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)

K-Number: K130816 · 2013-06-21

ApplicantNeuro Resource Group, Inc.
Decision Date2013-06-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) 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 2013-06-21 under 510(k) number K130816. 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 INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)?

INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is Neuro Resource Group, Inc.. The 510(k) number is K130816.

When did INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) receive FDA 510(k) clearance?

INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) received FDA 510(k) clearance on 2013-06-21, under 510(k) number K130816.

Who is the listed applicant for INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)?

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 INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)?

The FDA product code for INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) 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.

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Related Devices (Code: GXY)

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Official Source

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