510(k) Report

Devices descending from K920338

5 later devices reach Companion Retrofit Oxygen Concentration Indicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984295Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)Invacare Corp.19994—
+2K112402ULTRAMAXO2 Oxygen AnalyerMaxtec, LLC20112—
+2K072469Digiflo Concentrator AnalyzerDigiflo, Inc.20083—
+3K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs20260—
+3K250002Smart Check O2 (MA0236)Life Spark Medical, LLC20250—