De Novo DEN180057
- Device
- IB-Stim
- Contact
- tom carrico
- De Novo number
- DEN180057
- Product code
- QHH
- Regulation
- 876.5340
- Classification name
- non-implanted nerve stimulator for pain associated with irritable bowel syndrome (ibs)
- Decision
- granted (DENG)
- Decision date
- 2019-06-07
- Date received
- 2018-10-25
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QHH
- Device name
- Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.5340
- Implant
- N
- Life sustain/support
- N