510(k) Report

Devices descending from K110001

6 later devices reach Spacelabs Pathfinder SL Holter Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201921Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd.20210—
+1K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+1K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc.20114—
+2K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+2K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+3K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—