510(k) K942938

CROSSVENT-4 VENTILATOR by Bio-Med Devices, Inc. — Product Code CBK

K942938 is an FDA 510(k) premarket notification submitted by Bio-Med Devices, Inc. for the device "CROSSVENT-4 VENTILATOR". The FDA issued a decision of ST on September 19, 1995. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Bio-Med Devices, Inc. has at least 10 other 510(k) clearances on record.