# Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)
> **Product code: QYF** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1130
## Classification
- **FDA Product Code:** QYF
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.1130
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QYF)
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