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FDA 510(k)

NeuroStar TMS Therapy System

K-Number: K160703 · 2016-06-10

ApplicantNeuronetics, Inc.
Decision Date2016-06-10
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroStar TMS Therapy System is a medical device manufactured by Neuronetics, Inc.. It received FDA 510(k) clearance on 2016-06-10 under approval number K160703. 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 NeuroStar TMS Therapy System?

NeuroStar TMS Therapy System is a medical device that received FDA 510(k) clearance on 2016-06-10. It is manufactured by Neuronetics, Inc.. The 510(k) number is K160703.

When was NeuroStar TMS Therapy System approved by the FDA?

NeuroStar TMS Therapy System received FDA 510(k) clearance on 2016-06-10, under approval number K160703.

What company makes NeuroStar TMS Therapy System?

NeuroStar TMS Therapy System is manufactured by Neuronetics, Inc..

What is the FDA product code for NeuroStar TMS Therapy System?

The FDA product code for NeuroStar TMS Therapy System is OBP.

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Related PubMed Literature

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Other Devices by Neuronetics, Inc.

K161519NeuroStar TMS Therapy System K201158NeuroStar Advanced Therapy K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

View all 8 devices →

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar 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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