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FDA 510(k)

Neurosoft TMS

K-Number: K160309 · 2016-12-22

ApplicantTeleemg, LLC
Decision Date2016-12-22
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neurosoft TMS is a medical device manufactured by Teleemg, LLC. It received FDA 510(k) clearance on 2016-12-22 under approval number K160309. 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?

Neurosoft TMS is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Teleemg, LLC. The 510(k) number is K160309.

When was Neurosoft TMS approved by the FDA?

Neurosoft TMS received FDA 510(k) clearance on 2016-12-22, under approval number K160309.

What company makes Neurosoft TMS?

Neurosoft TMS is manufactured by Teleemg, LLC.

What is the FDA product code for Neurosoft TMS?

The FDA product code for Neurosoft TMS is OBP.

Other Devices by Teleemg, LLC

K173441Neurosoft TMS (also CloudTMS) K233742CloudTMS Edge for OCD K221129CloudTMS for OCD K250689CloudTMS Edge

Related Devices (Code: OBP)

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 K171051HORIZON Therapy SystemMagstim Company, 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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