Product code PFY
- Device name
- Low Patient Acuity Monitoring System
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2300
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.
- Source
- FDA openFDA device classification dataset