FDA 510(k)

Neurosoft TMS (also CloudTMS)

K-Number: K173441 · 2017-12-13

Decision Date2017-12-13

Product CodeOBP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Neurosoft TMS (also CloudTMS) is a medical device manufactured by Teleemg, LLC. It received FDA 510(k) clearance on 2017-12-13 under approval number K173441. 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 Neurosoft TMS (also CloudTMS)?

Neurosoft TMS (also CloudTMS) is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Teleemg, LLC. The 510(k) number is K173441.

When was Neurosoft TMS (also CloudTMS) approved by the FDA?

Neurosoft TMS (also CloudTMS) received FDA 510(k) clearance on 2017-12-13, under approval number K173441.

What company makes Neurosoft TMS (also CloudTMS)?

Neurosoft TMS (also CloudTMS) is manufactured by Teleemg, LLC.

What is the FDA product code for Neurosoft TMS (also CloudTMS)?

The FDA product code for Neurosoft TMS (also CloudTMS) is OBP.

Other Devices by Teleemg, LLC

K160309Neurosoft TMS K233742CloudTMS Edge for OCD K221129CloudTMS for OCD K250689CloudTMS Edge

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S K171051HORIZON Therapy SystemMagstim Company, Ltd.

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.