QYF — Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms) Class II
FDA product code QYF covers "Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)", a Class II medical device regulated under 21 CFR 870.1130. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- QYF
- Device Class
- Class II
- Regulation Number
- 870.1130
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.