510(k) K003445

FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 by Fresenius Medical Care North America — Product Code FIB

K003445 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2". The FDA issued a decision of Substantially Equivalent on December 1, 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.