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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 K130233
Device Name NEUROSTAR TMS THERAPY SYSTEM
Applicant
NEURONETICS
31 GENERAL WARREN BLVD
MALVERN,  PA  19355 -1245
Applicant Contact JUDY P WAYS, PH.D.
Correspondent
NEURONETICS
31 GENERAL WARREN BLVD
MALVERN,  PA  19355 -1245
Correspondent Contact JUDY P WAYS, PH.D.
Regulation Number882.5805
Classification Product Code
OBP  
Date Received01/30/2013
Decision Date 04/30/2013
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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