510(k) K123084

DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD by Elcam Medical Acal — Product Code FMG

K123084 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD". The FDA issued a decision of Substantially Equivalent on May 23, 2013. 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.