FDA 510(k)

Brainsway Deep (DTMS) System

K-Number: K173540 · 2018-05-03

Decision Date2018-05-03

Product CodeOBP

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 2018-05-03 under approval number K173540. The device is classified under product code OBP. 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 2018-05-03. It is manufactured by Brainsway , Ltd.. The 510(k) number is K173540.

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

Brainsway Deep (DTMS) System received FDA 510(k) clearance on 2018-05-03, under approval number K173540.

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 OBP.

Other Devices by Brainsway , Ltd.

K183303Brainsway Deep TMS System K200957Brainsway Deep TMS System K210201Deep Transcranial Magnetic Stimulation (DTMS) System K203735Brainsway Deep TMS System K203616Brainsway Deep (DTMS) System K220819BrainsWay Deep TMS System

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Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

Official Source

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