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FDA 510(k)

NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1

K-Number: K083538 · 2008-12-16

ApplicantNeuronetics
Decision Date2008-12-16
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics. It received FDA 510(k) clearance on 2008-12-16 under 510(k) number K083538. 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, MODEL 1.1?

NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Neuronetics. The 510(k) number is K083538.

When did NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 receive FDA 510(k) clearance?

NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 received FDA 510(k) clearance on 2008-12-16, under 510(k) number K083538.

Who is the listed applicant for NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1?

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, MODEL 1.1?

The FDA product code for NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 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.

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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)K130233NEUROSTAR TMS THERAPY SYSTEM

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

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

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