510(k) K983981

BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE by Bear Medical Systems, Inc. — Product Code CBK

K983981 is an FDA 510(k) premarket notification submitted by Bear Medical Systems, Inc. for the device "BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE". The FDA issued a decision of Substantially Equivalent on November 20, 1998. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Bear Medical Systems, Inc. has at least 10 other 510(k) clearances on record.