NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System 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, Neurostar Tms Therapy System, Neurostar Advanced Therapy System, Neurostar Advanced Therapy System For Mental Health.

Pre-market Notification Details

Device IDK222230
510k NumberK222230
Device Name:NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System For Mental Health
ClassificationTranscranial Magnetic Stimulator
Applicant Neuronetics, Inc. 3222 Phoenixville Pike Malvern,  PA  19355
ContactAmanda Pentecost
CorrespondentAmanda Pentecost
Neuronetics, Inc. 3222 Phoenixville Pike Malvern,  PA  19355
Product CodeOBP  
CFR Regulation Number882.5805 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-25
Decision Date2022-08-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850005944539 K222230 000

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