Skip to contentDe Novo DEN240074
- Device
- Pulsenmore ES
- Contact
- israel citron
- De Novo number
- DEN240074
- Product code
- SGJ
- Regulation
- 892.1590
- Classification name
- ultrasound imaging system for acquiring images at home by lay users
- Decision
- granted (DENG)
- Decision date
- 2025-10-31
- Date received
- 2024-12-11
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- SGJ
- Device name
- Ultrasound Imaging System For Acquiring Images At Home By Lay Users
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.1590
- Implant
- N
- Life sustain/support
- N