510(k) DEN130022
DEN130022 is an FDA 510(k) premarket notification submitted by Eneura Therapeutics for the device "NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR". The FDA issued a decision of De Novo Granted on December 13, 2013. The device falls under product code OKP (Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache), a Class II device regulated under 21 CFR 882.5808. Eneura Therapeutics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 13, 2013
- Date Received
- March 5, 2013
- Clearance Type
- Direct
- 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.