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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transcranial magnetic stimulator
510(k) Number K220127
Device Name NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Neuronetics, Inc
3222 Phoenixville Pike
Malvern,  PA  19355
Applicant Contact Cory Anderson
Neuronetics, Inc
3222 Phoenixville Pike
Malvern,  PA  19355
Correspondent Contact Robin Fatzinger
Regulation Number882.5805
Classification Product Code
Date Received01/18/2022
Decision Date 07/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No