510(k) K040142

ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE by Adac Laboratories — Product Code LLZ

K040142 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE". The FDA issued a decision of Substantially Equivalent on February 6, 2004. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Adac Laboratories has at least 10 other 510(k) clearances on record.