Brainsway Deep (DTMS) System— 510(k) K203616

Substantially Equivalent

Brainsway , Ltd.

FDA 510(k) clearance K203616 for Brainsway Deep (DTMS) System, Substantially Equivalent on 2021-04-16. Applicant: Brainsway , Ltd..

Clearance details

Applicant: Brainsway , Ltd.
Product code: Code QMD
Advisory panel: Neurology
Date received: 2020-12-10
Decision date: 2021-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

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