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FDA 510(k)

Cumulus Functional Neurophysiology Platform

K-Number: K221963 · 2023-04-27

ApplicantCumulus Neuroscience Limited
Decision Date2023-04-27
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cumulus Functional Neurophysiology Platform is the device name listed in this FDA 510(k) record. The listed applicant is Cumulus Neuroscience Limited. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K221963. 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 Cumulus Functional Neurophysiology Platform?

Cumulus Functional Neurophysiology Platform is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Cumulus Neuroscience Limited. The 510(k) number is K221963.

When did Cumulus Functional Neurophysiology Platform receive FDA 510(k) clearance?

Cumulus Functional Neurophysiology Platform received FDA 510(k) clearance on 2023-04-27, under 510(k) number K221963.

Who is the listed applicant for Cumulus Functional Neurophysiology Platform?

The FDA 510(k) record lists Cumulus Neuroscience Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cumulus Functional Neurophysiology Platform?

The FDA product code for Cumulus Functional Neurophysiology Platform is GWQ.

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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