510(k) K020746

BIRD TBIRD VELA VENTILATOR by Bird Products Corp. — Product Code CBK

K020746 is an FDA 510(k) premarket notification submitted by Bird Products Corp. for the device "BIRD TBIRD VELA VENTILATOR". The FDA issued a decision of Substantially Equivalent on April 22, 2002. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Bird Products Corp. has at least 10 other 510(k) clearances on record.