FDA 510(k)

New Wave System

K-Number: K260455 · 2026-03-13

Decision Date2026-03-13

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

New Wave System is the device name listed in this FDA 510(k) record. The listed applicant is Zeto, Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K260455. 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 New Wave System?

New Wave System is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Zeto, Inc.. The 510(k) number is K260455.

When did New Wave System receive FDA 510(k) clearance?

New Wave System received FDA 510(k) clearance on 2026-03-13, under 510(k) number K260455.

Who is the listed applicant for New Wave System?

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

What is the FDA product code for New Wave System?

The FDA product code for New Wave System is GWQ.

Other records listing Zeto, 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.

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Related Devices (Code: GWQ)

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.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.