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FDA 510(k)

SUBDURAL STRIP ELECTRODE

K-Number: K021144 · 2002-06-24

ApplicantNicolet Biomedical, Inc.
Decision Date2002-06-24
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SUBDURAL STRIP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical, Inc.. It received FDA 510(k) clearance on 2002-06-24 under 510(k) number K021144. 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 SUBDURAL STRIP ELECTRODE?

SUBDURAL STRIP ELECTRODE is a medical device that received FDA 510(k) clearance on 2002-06-24. The listed applicant is Nicolet Biomedical, Inc.. The 510(k) number is K021144.

When did SUBDURAL STRIP ELECTRODE receive FDA 510(k) clearance?

SUBDURAL STRIP ELECTRODE received FDA 510(k) clearance on 2002-06-24, under 510(k) number K021144.

Who is the listed applicant for SUBDURAL STRIP ELECTRODE?

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

What is the FDA product code for SUBDURAL STRIP ELECTRODE?

The FDA product code for SUBDURAL STRIP ELECTRODE is GYC.

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Other records listing Nicolet Biomedical, Inc. as applicant

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Related Devices (Code: GYC)

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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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