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FDA 510(k)

REUSABLE STIMULATING ELECTRODES

K-Number: K111270 · 2011-09-13

ApplicantBio Protech, Inc.
Decision Date2011-09-13
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REUSABLE STIMULATING ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Bio Protech, Inc.. It received FDA 510(k) clearance on 2011-09-13 under 510(k) number K111270. 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 REUSABLE STIMULATING ELECTRODES?

REUSABLE STIMULATING ELECTRODES is a medical device that received FDA 510(k) clearance on 2011-09-13. The listed applicant is Bio Protech, Inc.. The 510(k) number is K111270.

When did REUSABLE STIMULATING ELECTRODES receive FDA 510(k) clearance?

REUSABLE STIMULATING ELECTRODES received FDA 510(k) clearance on 2011-09-13, under 510(k) number K111270.

Who is the listed applicant for REUSABLE STIMULATING ELECTRODES?

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

What is the FDA product code for REUSABLE STIMULATING ELECTRODES?

The FDA product code for REUSABLE STIMULATING ELECTRODES is GXY.

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Other records listing Bio Protech, Inc. as applicant

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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

View on FDA Database →

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

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