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FDA 510(k)

KIMSTIM AURICULAR ELECTRODE

K-Number: K011691 · 2001-12-27

ApplicantKim Institute For Rehabilitation Medicine, P.C.
Decision Date2001-12-27
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KIMSTIM AURICULAR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Kim Institute For Rehabilitation Medicine, P.C.. It received FDA 510(k) clearance on 2001-12-27 under 510(k) number K011691. 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 KIMSTIM AURICULAR ELECTRODE?

KIMSTIM AURICULAR ELECTRODE is a medical device that received FDA 510(k) clearance on 2001-12-27. The listed applicant is Kim Institute For Rehabilitation Medicine, P.C.. The 510(k) number is K011691.

When did KIMSTIM AURICULAR ELECTRODE receive FDA 510(k) clearance?

KIMSTIM AURICULAR ELECTRODE received FDA 510(k) clearance on 2001-12-27, under 510(k) number K011691.

Who is the listed applicant for KIMSTIM AURICULAR ELECTRODE?

The FDA 510(k) record lists Kim Institute For Rehabilitation Medicine, P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIMSTIM AURICULAR ELECTRODE?

The FDA product code for KIMSTIM AURICULAR ELECTRODE is GXY.

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Official Source

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