Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEUROSTAR TMS THERAPY SYSTEM

K-Number: K130233 · 2013-04-30

ApplicantNeuronetics
Decision Date2013-04-30
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSTAR TMS THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics. It received FDA 510(k) clearance on 2013-04-30 under 510(k) number K130233. 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 2013-04-30. The listed applicant is Neuronetics. The 510(k) number is K130233.

When did NEUROSTAR TMS THERAPY SYSTEM receive FDA 510(k) clearance?

NEUROSTAR TMS THERAPY SYSTEM received FDA 510(k) clearance on 2013-04-30, under 510(k) number K130233.

Who is the listed applicant for NEUROSTAR TMS THERAPY SYSTEM?

The FDA 510(k) record lists Neuronetics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROSTAR TMS THERAPY SYSTEM?

The FDA product code for NEUROSTAR TMS THERAPY SYSTEM is OBP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Neuronetics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233621NeuroStar Advanced Therapy System (Version 3.8)K231350OCD MT Cap (85-00397-000)K230029NeuroStar Advanced Therapy System (Version 3.7)K083538NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co.K260691BTL-699BTL Industries, Inc.K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj

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.

↑