510(k) K190489

Elcam Stopcocks and Manifolds by Elcam Medical Acal — Product Code FMG

K190489 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "Elcam Stopcocks and Manifolds". The FDA issued a decision of Substantially Equivalent on April 23, 2019. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Elcam Medical Acal has at least 10 other 510(k) clearances on record.