510(k) K771368

PORTABLE INFANT VENTILATOR by Cavitron Corp. — Product Code FOC

K771368 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "PORTABLE INFANT VENTILATOR". The FDA issued a decision of Substantially Equivalent on August 4, 1977. The device falls under product code FOC (Bag, Urine Collection, Newborn), a Class II device regulated under 21 CFR 876.5250. Cavitron Corp. has at least 10 other 510(k) clearances on record.