510(k) K000702

BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR by Fresenius Medical Care North America — Product Code FIB

K000702 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR". The FDA issued a decision of Substantially Equivalent on June 7, 2000. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.