510(k) K935778

VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM by Via Medical Corp. — Product Code CCE

K935778 is an FDA 510(k) premarket notification submitted by Via Medical Corp. for the device "VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM". The FDA issued a decision of Substantially Equivalent (kit, denovo) on December 5, 1996. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200. Via Medical Corp. has at least 3 other 510(k) clearances on record.