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FDA 510(k)

Brainsway Deep (DTMS) System

K-Number: K203616 · 2021-04-16

ApplicantBrainsway , Ltd.
Decision Date2021-04-16
Product CodeQMD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Brainsway Deep (DTMS) System is a medical device manufactured by Brainsway , Ltd.. It received FDA 510(k) clearance on 2021-04-16 under approval number K203616. The device is classified under product code QMD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainsway Deep (DTMS) System?

Brainsway Deep (DTMS) System is a medical device that received FDA 510(k) clearance on 2021-04-16. It is manufactured by Brainsway , Ltd.. The 510(k) number is K203616.

When was Brainsway Deep (DTMS) System approved by the FDA?

Brainsway Deep (DTMS) System received FDA 510(k) clearance on 2021-04-16, under approval number K203616.

What company makes Brainsway Deep (DTMS) System?

Brainsway Deep (DTMS) System is manufactured by Brainsway , Ltd..

What is the FDA product code for Brainsway Deep (DTMS) System?

The FDA product code for Brainsway Deep (DTMS) System is QMD.

Other Devices by Brainsway , Ltd.

K173540Brainsway Deep (DTMS) System K183303Brainsway Deep TMS System K200957Brainsway Deep TMS System K210201Deep Transcranial Magnetic Stimulation (DTMS) System K203735Brainsway Deep TMS System K220819BrainsWay Deep TMS System

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Related Devices (Code: QMD)

K200957Brainsway Deep TMS SystemBrainsway , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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