510(k) Report

Devices descending from K123043

11 later devices reach Irma C02 Model 200101; Irma AX 200601 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.20250—
+1K140264MADMThornhill Research, Inc.20150—
+1K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+2K160481Vivo 60Breas Medical AB201672
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+3K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K233452Vivo 45 LSBreas Medical AB202501
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—