NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy For Mental Health

Transcranial Magnetic Stimulator

Neuronetics, Inc

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

Pre-market Notification Details

Device IDK220127
510k NumberK220127
Device Name:NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy For Mental Health
ClassificationTranscranial Magnetic Stimulator
Applicant Neuronetics, Inc 3222 Phoenixville Pike Malvern,  PA  19355
ContactCory Anderson
CorrespondentRobin Fatzinger
Neuronetics, Inc 3222 Phoenixville Pike Malvern,  PA  19355
Product CodeOBP  
CFR Regulation Number882.5805 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-18
Decision Date2022-07-15

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