510(k) K864589

TRI-SERVICE OMV VAPORIZER by Bear Medical Systems, Inc. — Product Code BSZ

K864589 is an FDA 510(k) premarket notification submitted by Bear Medical Systems, Inc. for the device "TRI-SERVICE OMV VAPORIZER". The FDA issued a decision of Substantially Equivalent on June 5, 1987. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Bear Medical Systems, Inc. has at least 10 other 510(k) clearances on record.