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FDA 510(k)

NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM

K-Number: K042626 · 2005-03-28

ApplicantCyberkinetics, Inc.
Decision Date2005-03-28
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cyberkinetics, Inc.. It received FDA 510(k) clearance on 2005-03-28 under 510(k) number K042626. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM?

NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-28. The listed applicant is Cyberkinetics, Inc.. The 510(k) number is K042626.

When did NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM receive FDA 510(k) clearance?

NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM received FDA 510(k) clearance on 2005-03-28, under 510(k) number K042626.

Who is the listed applicant for NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM?

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

What is the FDA product code for NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM?

The FDA product code for NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM is GWQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Cyberkinetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060523NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM

Related Devices (Code: GWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.

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