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 Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ) (1) Device, Muscle Monitoring (KZM) (1)