510(k) K940054

MEASURED VOLUME SOLUTION ADMINISTRATION SET by Puritas Health Care, Inc. — Product Code FPA

K940054 is an FDA 510(k) premarket notification submitted by Puritas Health Care, Inc. for the device "MEASURED VOLUME SOLUTION ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on April 15, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Puritas Health Care, Inc. has at least 10 other 510(k) clearances on record.