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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 K083538
Device Name NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
Applicant
NEURONETICS
ONE GREAT VALLEY PKWY.
STE.2
MALVERN,  PA  19355
Applicant Contact JUDY P WAYS
Correspondent
NEURONETICS
ONE GREAT VALLEY PKWY.
STE.2
MALVERN,  PA  19355
Correspondent Contact JUDY P WAYS
Regulation Number882.5805
Classification Product Code
OBP  
Date Received11/28/2008
Decision Date 12/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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