510(k) K142081

CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES by Osprey Medical, Inc. — Product Code DXT

K142081 is an FDA 510(k) premarket notification submitted by Osprey Medical, Inc. for the device "CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES". The FDA issued a decision of Substantially Equivalent on Dec 12, 2014. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Osprey Medical, Inc. has at least 10 other 510(k) clearances on record.