510(k) K760039

VALVE, I.M.V. (U-MID ONE WAY) by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code CBO

K760039 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "VALVE, I.M.V. (U-MID ONE WAY)". The FDA issued a decision of Substantially Equivalent on July 16, 1976. The device falls under product code CBO (Attachment, Intermittent Mandatory Ventilation (Imv)), a Class II device regulated under 21 CFR 868.5955. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.