Product code PJA
- Device name
- Coronary Vascular Physiologic Simulation Software
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1415
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
- Source
- FDA openFDA device classification dataset