510(k) K884216

506 NON-INVASIVE VITAL SIGNS MONITOR by Criticare Systems, Inc. — Product Code DSI

K884216 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "506 NON-INVASIVE VITAL SIGNS MONITOR". The FDA issued a decision of Substantially Equivalent on March 16, 1989. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Criticare Systems, Inc. has at least 10 other 510(k) clearances on record.