Product code QYF
- Device name
- Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1130
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring.
- Source
- FDA openFDA device classification dataset