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510(k) K083538

NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 by Neuronetics — Product Code OBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2008
Date Received
November 28, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulator
Device Class
Class II
Regulation Number
882.5805
Review Panel
NE
Submission Type

A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.

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