De Novo DEN180042
- Device
- Irregular Rhythm Notification Feature
- Contact
- donna-bea tillman
- De Novo number
- DEN180042
- Product code
- QDB
- Regulation
- 870.2790
- Classification name
- photoplethysmograph analysis software for over-the-counter use
- Decision
- granted (DENG)
- Decision date
- 2018-09-11
- Date received
- 2018-08-09
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- QDB
- Device name
- Photoplethysmograph Analysis Software For Over-The-Counter Use
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.2790
- Implant
- N
- Life sustain/support
- N