510(k) K970738

KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT by Jamieson Film Co. — Product Code IZI

K970738 is an FDA 510(k) premarket notification submitted by Jamieson Film Co. for the device "KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT". The FDA issued a decision of Substantially Equivalent on May 7, 1997. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Jamieson Film Co. has at least 5 other 510(k) clearances on record.