Brainsway Deep TMS System— 510(k) K183303

Substantially Equivalent

Brainsway , Ltd.

FDA 510(k) clearance K183303 for Brainsway Deep TMS System, Substantially Equivalent on 2019-03-08. Applicant: Brainsway , Ltd.. Device class: 2.

Clearance details

Applicant: Brainsway , Ltd.
Product code: Code QCI
Device class: Class 2
Regulation: 21 CFR 882.5802
Advisory panel: Neurology
Date received: 2018-11-27
Decision date: 2019-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

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