Brainsway Deep TMS System— 510(k) K200957

Substantially Equivalent

Brainsway , Ltd.

FDA 510(k) clearance K200957 for Brainsway Deep TMS System, Substantially Equivalent on 2020-08-21. 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: 2020-04-09
Decision date: 2020-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QMD

K203616 — Brainsway Deep (DTMS) System2021-04-16

More clearances from Brainsway , Ltd.

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K222196 — Deep TMS System2024-05-31
K220819 — BrainsWay Deep TMS System2022-08-26
K210201 — Deep Transcranial Magnetic Stimulation (DTMS) System2021-08-17

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