510(k) Report

Devices descending from K030348

2 later devices reach Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133149Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.20140—
+1K112331Biopure Portable RO SystemsArion Water, Inc.20120—