510(k) K182976
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2019
- Date Received
- October 26, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
- Device Class
- Class II
- Regulation Number
- 882.5808
- Review Panel
- NE
- Submission Type
Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache.