K260455
- 510(k) number
- K260455
- Device name
- New Wave System
- Applicant
- Zeto, Inc. NC · US
- Product code
- GWQ — Full-Montage Standard Electroencephalograph
- Decision date
- 2026-03-13
- Date received
- 2026-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260455.pdf
Official FDA record: K260455
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.