510(k) Report

Devices descending from K043006

4 later devices reach Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100920Mesa II Oxygen Concentrator Model: T2000 SeriesSequal Technologies Co., Ltd.20100—
+1K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.20062—
+2K131626Exceleron Bacterial FiltersExceleron Medical20140—
+2K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries20101—