510(k) K011899

PF 5050 PRESSURE UNIT, MODEL PF 5050 by Perimed AB — Product Code DPW

K011899 is an FDA 510(k) premarket notification submitted by Perimed AB for the device "PF 5050 PRESSURE UNIT, MODEL PF 5050". The FDA issued a decision of Substantially Equivalent on November 6, 2001. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Perimed AB has at least 9 other 510(k) clearances on record.