510(k) K192398

Millenium HX by Mar Cor Purification, Inc. — Product Code FIP

K192398 is an FDA 510(k) premarket notification submitted by Mar Cor Purification, Inc. for the device "Millenium HX". The FDA issued a decision of Substantially Equivalent on October 3, 2019. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Mar Cor Purification, Inc. has at least 3 other 510(k) clearances on record.