Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Scale, Stand-On, Patient (FRI) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1)