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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 Stimulation System For Obsessive-Compulsive Disorder
510(k) Number K212289
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
Applicant
Neuronetics, Inc.
3222 Phoenixville Pike
Malvern,  PA  19355
Applicant Contact Cory Anderson
Correspondent
Neuronetics, Inc.
3222 Phoenixville Pike
Malvern,  PA  19355
Correspondent Contact Robin Fatzinger
Regulation Number882.5802
Classification Product Code
QCI  
Date Received07/21/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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