WAVi SCAN EEG System and Accessories— 510(k) K213900

Substantially Equivalent

Wavi Co.

FDA 510(k) clearance K213900 for WAVi SCAN EEG System and Accessories, Substantially Equivalent on 2022-05-06. Applicant: Wavi Co.. Device class: 2.

Clearance details

Applicant: Wavi Co.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2021-12-14
Decision date: 2022-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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