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.