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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 K231350
Device Name OCD MT Cap (85-00397-000)
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 Number882.5802
Classification Product Code
QCI  
Subsequent Product Code
OBP  
Date Received05/09/2023
Decision Date 06/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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