MeRT System— 510(k) K260402

Substantially Equivalent

Wave Neuroscience

FDA 510(k) clearance K260402 for MeRT System, Substantially Equivalent on 2026-06-03. Applicant: Wave Neuroscience. Device class: 2.

Clearance details

Applicant
Wave Neuroscience
Product code
Code SIG
Device class
Class 2
Regulation
21 CFR 882.5802
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newport Beach, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.