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 Monitor, Breathing Frequency (BZQ) (1) Oximeter (DQA) (1) System, Network And Communication, Physiological Monitors (MSX) (1) Thermometer, Electronic, Clinical (FLL) (1) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (1)