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FDA 510(k)

NEUROPORT ELECTRODE

K-Number: K070272 · 2007-08-03

ApplicantCyberkinetics Neurotechnology Systems, Inc.
Decision Date2007-08-03
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPORT ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Cyberkinetics Neurotechnology Systems, Inc.. It received FDA 510(k) clearance on 2007-08-03 under 510(k) number K070272. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROPORT ELECTRODE?

NEUROPORT ELECTRODE is a medical device that received FDA 510(k) clearance on 2007-08-03. The listed applicant is Cyberkinetics Neurotechnology Systems, Inc.. The 510(k) number is K070272.

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

NEUROPORT ELECTRODE received FDA 510(k) clearance on 2007-08-03, under 510(k) number K070272.

Who is the listed applicant for NEUROPORT ELECTRODE?

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

What is the FDA product code for NEUROPORT ELECTRODE?

The FDA product code for NEUROPORT ELECTRODE is GZL.

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Related Devices (Code: GZL)

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Official Source

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