510(k) K232235
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2023
- Date Received
- July 27, 2023
- Clearance Type
- Traditional
- 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.