510(k) K973917

CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM by Sims Deltec, Inc. — Product Code FRN

K973917 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM". The FDA issued a decision of Substantially Equivalent on January 9, 1998. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Sims Deltec, Inc. has at least 10 other 510(k) clearances on record.