FDA 510(k)

Q21

K-Number: K221959 · 2023-08-31

Decision Date2023-08-31

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Q21 is the device name listed in this FDA 510(k) record. The listed applicant is Neurofield, Inc.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K221959. 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 Q21?

Q21 is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Neurofield, Inc.. The 510(k) number is K221959.

When did Q21 receive FDA 510(k) clearance?

Q21 received FDA 510(k) clearance on 2023-08-31, under 510(k) number K221959.

Who is the listed applicant for Q21?

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

What is the FDA product code for Q21?

The FDA product code for Q21 is GWQ.

Other records listing Neurofield, 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.

K252951Genesis Sleep K240420NeuroField Analysis Suite

Related Devices (Code: GWQ)

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 Sas K231457SPARK ScanSpark Neuro, Inc.K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited

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.