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.. Device class: 2.

Clearance details

Applicant: Brainsway , Ltd.
Product code: Code QMD
Device class: Class 2
Regulation: 21 CFR 882.5802
Advisory panel: Neurology
Date received: 2020-12-10
Decision date: 2021-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QMD

K200957 — Brainsway Deep TMS System2020-08-21

More clearances from Brainsway , Ltd.

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K222196 — Deep TMS System2024-05-31
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K210201 — Deep Transcranial Magnetic Stimulation (DTMS) System2021-08-17

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