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FDA 510(k)

DISPOSABLE ELECTRODE

K-Number: K111737 · 2011-10-14

ApplicantSanibel Supply
Decision Date2011-10-14
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Sanibel Supply. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K111737. 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 DISPOSABLE ELECTRODE?

DISPOSABLE ELECTRODE is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Sanibel Supply. The 510(k) number is K111737.

When did DISPOSABLE ELECTRODE receive FDA 510(k) clearance?

DISPOSABLE ELECTRODE received FDA 510(k) clearance on 2011-10-14, under 510(k) number K111737.

Who is the listed applicant for DISPOSABLE ELECTRODE?

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

What is the FDA product code for DISPOSABLE ELECTRODE?

The FDA product code for DISPOSABLE ELECTRODE is GXY.

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Official Source

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