De Novo DEN130015
- Device
- PIXEL 3 SYSTEM
- Contact
- peggy mclaughlin
- De Novo number
- DEN130015
- Product code
- PBZ
- Regulation
- 880.2750
- Classification name
- image processing device for estimation of external blood loss
- Decision
- granted (DENG)
- Decision date
- 2014-05-09
- Date received
- 2013-02-04
- Classification advisory
- General Hospital
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- PBZ
- Device name
- Image Processing Device For Estimation Of External Blood Loss
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.2750
- Implant
- N
- Life sustain/support
- N