FDA 510(k)

NICOLET CORTICAL STIMULATOR

K-Number: K072964 · 2008-12-30

Decision Date2008-12-30

Product CodeGYC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NICOLET CORTICAL STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2008-12-30 under 510(k) number K072964. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICOLET CORTICAL STIMULATOR?

NICOLET CORTICAL STIMULATOR is a medical device that received FDA 510(k) clearance on 2008-12-30. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K072964.

When did NICOLET CORTICAL STIMULATOR receive FDA 510(k) clearance?

NICOLET CORTICAL STIMULATOR received FDA 510(k) clearance on 2008-12-30, under 510(k) number K072964.

Who is the listed applicant for NICOLET CORTICAL STIMULATOR?

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

What is the FDA product code for NICOLET CORTICAL STIMULATOR?

The FDA product code for NICOLET CORTICAL STIMULATOR is GYC.

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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.