New Wave System— 510(k) K260455

Substantially Equivalent

Zeto, Inc.

FDA 510(k) clearance K260455 for New Wave System, Substantially Equivalent on 2026-03-13. Applicant: Zeto, Inc..

Clearance details

Applicant: Zeto, Inc.
Product code: Code GWQ
Advisory panel: Neurology
Date received: 2026-02-11
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Raleigh, NC, US

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