NeuroStar Advanced Therapy For Adjunctive Treatment Of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy For Mental Health, NeuroStar

Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder

Neuronetics, Inc

The following data is part of a premarket notification filed by Neuronetics, Inc with the FDA for Neurostar Advanced Therapy For Adjunctive Treatment Of Ocd, Neurostar Advanced Therapy System, Neurostar Tms Therapy System, Neurostar Advanced Therapy For Mental Health, Neurostar.

Pre-market Notification Details

Device IDK212289
510k NumberK212289
Device Name:NeuroStar Advanced Therapy For Adjunctive Treatment Of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy For Mental Health, NeuroStar
ClassificationTranscranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Applicant Neuronetics, Inc 3222 Phoenixville Pike Malvern,  PA  19355
ContactCory Anderson
CorrespondentRobin Fatzinger
Neuronetics, Inc 3222 Phoenixville Pike Malvern,  PA  19355
Product CodeQCI  
CFR Regulation Number882.5802 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-21
Decision Date2022-05-06

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