510(k) K830165

BEAR JET 150 VENTILATOR by Bear Medical Systems, Inc. — Product Code FLI

K830165 is an FDA 510(k) premarket notification submitted by Bear Medical Systems, Inc. for the device "BEAR JET 150 VENTILATOR". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code FLI (Cabinet, Ethylene-Oxide Gas Aerator), a Class II device regulated under 21 CFR 880.6100. Bear Medical Systems, Inc. has at least 10 other 510(k) clearances on record.