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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 K230029
Device Name NeuroStar Advanced Therapy System (Version 3.7)
Applicant
Neuronetics
3222 Phoenixville Pike
Malvern,  PA  19355
Applicant Contact Amanda Pentecost
Correspondent
Neuronetics
3222 Phoenixville Pike
Malvern,  PA  19355
Correspondent Contact Amanda Pentecost
Regulation Number882.5805
Classification Product Code
OBP  
Subsequent Product Code
QCI  
Date Received01/04/2023
Decision Date 04/04/2023
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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