510(k) K840919

DAYPAK SYS VII CATHETER CARE KIT by Creative Care Systems, Inc. — Product Code KLK

K840919 is an FDA 510(k) premarket notification submitted by Creative Care Systems, Inc. for the device "DAYPAK SYS VII CATHETER CARE KIT". The FDA issued a decision of Substantially Equivalent on April 17, 1984. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Creative Care Systems, Inc. has at least 6 other 510(k) clearances on record.