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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 K133408
Device Name NEUROSTAR TMS THERAPY SYSTEM
Applicant
Neuronetics
3222 Phoenixville Pike
Malvern,  PA  19355 -1245
Applicant Contact JUDY P WAYS, PH.D.
Correspondent
Neuronetics
3222 Phoenixville Pike
Malvern,  PA  19355 -1245
Correspondent Contact JUDY P WAYS, PH.D.
Regulation Number882.5805
Classification Product Code
OBP  
Date Received11/06/2013
Decision Date 03/28/2014
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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