510(k) Report

Devices descending from K983500

4 later devices reach PRO2 Check Oxygen Indicator through their predicates, nearest generation first.

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