510(k) DEN200030
- Device
- FEops HEARTguide
- Applicant
- Feops NV
- 510(k) number
- DEN200030
- Product code
- QQI
- Decision
- Unknown (DENG)
- Decision date
- 2021-09-08
- Date received
- 2020-05-07
- Regulation
- 870.1405
- Classification name
- Interventional Cardiovascular Implant Simulation Software Device
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sofie Van Cauter
- Address
- Technologiepark 122 Gent-Zwijnaarde BE 9052 9052
FDA Registration Numbers#
- 3020703662
- 3030707552
Source Documents#
510(k) summary PDF not indicated by FDA