New Wave System— 510(k) K260455
Substantially EquivalentZeto, Inc.
FDA 510(k) clearance K260455 for New Wave System, Substantially Equivalent on 2026-03-13. Applicant: Zeto, Inc.. Device class: 2.
Summary
Zeto's New Wave System is filed under GWQ, full-montage standard electroencephalographs. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel. It was a Special 510(k).
Zeto filed from Raleigh, North Carolina. The decision came 30 calendar days after receipt (February 11 to March 13, 2026).
Clearance details
- Applicant
- Zeto, Inc.
- Product code
- Product code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Raleigh, NC, US
Recent devices under product code GWQ
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