510(k) K020018

MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE by Cardiopulmonary Corp. — Product Code MSX

K020018 is an FDA 510(k) premarket notification submitted by Cardiopulmonary Corp. for the device "MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE". The FDA issued a decision of Substantially Equivalent on February 21, 2002. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Cardiopulmonary Corp. has at least 8 other 510(k) clearances on record.