FDA product code QYF

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

Cardiovascular·Class 2·21 CFR 870.1130
US regulatory classifications
US Product Code (FDA)
QYF
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.1130
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms) is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.