NZK — Stimulator, Low Electric Field, Tumor Treatment Class III
FDA product code NZK covers "Stimulator, Low Electric Field, Tumor Treatment", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- NZK
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- No
Definition
Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.