510(k) K990429

MODIFICATION OF VENTURI VENTILATOR by Cardiopulmonary Corp. — Product Code CBK

K990429 is an FDA 510(k) premarket notification submitted by Cardiopulmonary Corp. for the device "MODIFICATION OF VENTURI VENTILATOR". The FDA issued a decision of ST on February 24, 1999. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Cardiopulmonary Corp. has at least 8 other 510(k) clearances on record.