510(k) K091461

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE by Cardiopulmonary Corp. — Product Code MOD

K091461 is an FDA 510(k) premarket notification submitted by Cardiopulmonary Corp. for the device "BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE". The FDA issued a decision of Substantially Equivalent on August 14, 2009. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Cardiopulmonary Corp. has at least 8 other 510(k) clearances on record.