QYF

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

Product code

QYF

Device name

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

Device class

Class 2

21 CFR

21 CFR 870.1130

Medical specialty

Cardiovascular

Marketing pathway

510(K)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).