510(k) K973133

BIG BAG 3000 PRESSURE INFUSOR by Byron Medical — Product Code FRN

K973133 is an FDA 510(k) premarket notification submitted by Byron Medical for the device "BIG BAG 3000 PRESSURE INFUSOR". The FDA issued a decision of ST on September 12, 1997. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Byron Medical has at least 10 other 510(k) clearances on record.