De Novo DEN100002
- Device
- INFRASCANNER, MODEL 1000
- Contact
- steven b datlof
- De Novo number
- DEN100002
- Product code
- OPT
- Regulation
- 882.1935
- Classification name
- infrared hematoma detector
- Decision
- granted (DENG)
- Decision date
- 2011-12-13
- Date received
- 2010-04-08
- Classification advisory
- Ophthalmic
- Review advisory
- Neurology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OPT
- Device name
- Infrared Hematoma Detector
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 882.1935
- Implant
- N
- Life sustain/support
- N